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CompletedNCT00608491CARRESSUpdated Jun 24, 2013Results posted

Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)

A Phase 3 interventional study of Stepped pharmacologic care and Ultrafiltration in Heart Failure, sponsored by Duke University. Completed at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.

Sponsored by Duke University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Heart failure is a serious condition in which the heart's ability to pump blood through the body is impaired, often making a person feel weak or fatigued. When a person's condition worsens to the point of hospitalization, that person is said to have acute decompensated heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as cardiorenal syndrome, is a common complication of heart failure and causes further medical problems and need for hospitalization. While there are various effective treatments for heart failure, more research is needed to determine the best treatment for targeting both ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.

Read the detailed description

Heart failure is a common condition that affects approximately 5 million people in the United States, with 550,000 new cases diagnosed each year. Common symptoms of heart failure include swelling and fluid buildup in the legs, feet, and/or lungs; shortness of breath; coughing; elevated heart rate; change in appetite; and fatigue. If left untreated, the condition of the heart may deteriorate so far that the person undergoes ADHF. The number of hospitalizations attributed to ADHF has risen significantly, with many people readmitted soon after discharge because of recurring symptoms or further medical complications, such as cardiorenal syndrome. Current heart failure treatments focus on removing excess fluid buildup, often by increasing urination with diuretic medications or by draining directly from the veins. Direct drainage from the veins, also known as ultrafiltration, may be the more effective method for treating people with ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.

Participation in this study will last 60 days. All potential participants will undergo initial screening, which will include a medical history, physical exam, blood draws, measurements of fluid intake and urine output, and questionnaires. These same evaluations and procedures will be repeated at various points during the hospital stay. Eligible participants will be randomly assigned to receive standard medical drug therapy or fluid removal by ultrafiltration. Standard medical drug therapy will involve the intravenous delivery of diuretics and possibly other doctor-recommended medications. Ultrafiltration will involve intravenously removing blood, passing it through an ultrafiltration device, and then returning the blood to the participant. During ultrafiltration, participants will be treated with a blood thinner through the IV, as well.

Follow-up assessments will occur at Days 30 and 60 after treatment. Follow-up assessments will include measurements of fluid intake, urine output, and vital signs; blood draws; physical exams; and questions about medications and status of recovery.

02

Conditions studied

  • Heart Failure

Keywords

  • Acute Decompensated Heart Failure
  • Acute Decompensated Heart Failure With Cardiorenal Syndrome
  • Cardiorenal Syndrome
  • Persistent Congestion
  • Ultra Filtration
03

In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's enrollment of 188 is above the median of 60 across 46 interventional studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 18 or older
  • admitted to the hospital with a primary diagnosis of decompensated heart failure
  • onset of cardiorenal syndrome after hospitalization or pre-hospitalization
  • after hospitalization - onset of cardiorenal syndrome after hospitalization must occur within 10 days from the time of admission after receiving IV diuretics
  • pre-hospitalization - onset of cardiorenal syndrome pre-hospitalization must occur within 12 weeks of the index hospitalization in the setting of escalating doses of outpatient diuretics
  • persistent volume overload

Exclusion criteria

Exclusion criteria:

  • intravascular volume depletion based on investigator"s clinical assessment
  • acute coronary syndrome within 4 weeks
  • indication for hemodialysis
  • creatinine > 3.5 mg per deciliter at admission to the hospital
  • systolic blood pressure \< 90 mmHg at the time of enrollment
  • alternative explanation for worsening renal function such as obstructive nephropathy,contrast induced nephropathy, acute tubular necrosis
  • Hematocrit > 45%
  • poor venous access
  • clinical instability likely to require the addition of intravenous vasoactive drugs including vasodilators and/or inotropic agents
  • allergy or contraindications to the use of heparin
  • the use of iodinated radio contrast material in the last 72 hours or anticipated use of IV contrast during the current hospitalization
  • known bilateral renal artery stenosis
  • active myocarditis
  • hypertrophic obstructive cardiomyopathy
  • severe valvular stenosis
  • complex congenital heart disease
  • sepsis or ongoing systemic infection
  • enrollment in another clinical trial involving medical or device based interventions
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • Active comparator
    Stepped pharmacologic care

    Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.

    Drug: Stepped pharmacologic care

  • Experimental
    Ultrafiltration

    All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.

    Device: Ultrafiltration

Interventions

  • DrugStepped pharmacologic care

    Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.

  • DeviceUltrafiltration

    All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.

06

What researchers measure

Primary outcomes

  1. Change in Serum Creatinine

    Time frame: Change from Baseline to Day 4

  2. Change in Weight

    Time frame: Change from Baseline to Day 4

Secondary outcomes

  1. Change in Glomerular Filtration Rate

    Time frame: Change from Baseline to Day 4

  2. Change in Serum Creatinine

    Time frame: Change from Baseline to Day 7

  3. Change in Glomerular Filtration Rate

    Time frame: Change from Baseline to Day 7

  4. Changes in Weight

    Time frame: Change from Baseline to Day 1

  5. Changes in Weight

    Time frame: Change from Baseline to Day 2

  6. Change in Weight

    Time frame: Change from Baseline to Day 3

  7. Changes in Weight

    Time frame: Change from Baseline to Day 5

  8. Change in Weight

    Time frame: Change from Baseline to Day 6

  9. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 1

  10. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 2

  11. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 3

  12. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 4

  13. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 5

  14. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 6

  15. Cumulative Net Fluid Loss

    Time frame: Randomization through Day 7

  16. Dyspnea Visual Analog Scale

    Scale range: -100 , +100 -100=worse, +100=better

    Time frame: Change from Baseline to Day 4

  17. Change in Global Visual Analog Scale

    Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".

    Time frame: Change from Baseline to Day 4

  18. Change in Dyspnea Visual Analog Scale

    Scale range: -100 , +100 -100=worse, +100=better

    Time frame: Baseline to Day 7/Discharge

  19. Change in Global Visual Analog Scale

    Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".

    Time frame: Baseline to Day 7/Discharge

  20. Change in Furosemide-Equivalent Dose

    Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

    Time frame: Baseline to Day 7/Discharge

  21. Change in Blood Sodium Level

    Time frame: Baseline to Day 4

  22. Change in Blood Potassium Level

    Time frame: Baseline to Day 4

  23. Change in Blood Urea Nitrogen/Urea

    Time frame: Baseline to Day 4

  24. Change in Blood Bicarbonate Level

    Time frame: Baseline to Day 4

  25. Change in Blood Hemoglobin Level

    Time frame: Baseline to Day 4

  26. Change in Blood Sodium Level

    Time frame: Baseline to Day 7/Discharge

  27. Change in Blood Potassium Level

    Time frame: Baseline to Day 7/Discharge

  28. Change in Blood Urea Nitrogen/Urea

    Time frame: Baseline to Day 7/Discharge

  29. Change in Blood Bicarbonate Level

    Time frame: Baseline to Day 7/Discharge

  30. Change in Blood Hemoglobin Level

    Time frame: Baseline to Day 7/Discharge

  31. Change in Blood Cystatin C

    Time frame: Baseline to Day 4

  32. Change in Uric Acid

    Time frame: Baseline to Day 4

  33. Change in Blood N- Terminal Pro- BNP

    Time frame: Baseline to Day 4

  34. Change in Plasma Renin Activity

    Time frame: Baseline to Day 4

  35. Change in Blood High Sensitivity Troponin I

    Time frame: Baseline to Day 4

  36. Change in Blood Aldosterone

    Time frame: Baseline to Day 4

  37. Change in Blood Procollagen III N-terminal Propepide

    Time frame: Baseline to Day 4

  38. Change in Blood Endothelin-1

    Time frame: Baseline to Day 4

  39. Change in Blood High Sensitivity C-Reactive Protein

    Time frame: Baseline to Day 4

  40. Change in Blood Carboxy-terminal Telopeptide of Collagen Type I

    Time frame: Baseline to Day 4

  41. Change in Blood Cystatin C

    Time frame: Baseline to Day 7/Discharge

  42. Change in Blood Uric Acid

    Time frame: Baseline to Day 7/Discharge

  43. Change in Blood N Terminal Pro-Natriuretic Peptide

    Time frame: Baseline to Day 7/Discharge

  44. Change in Plasma Renin Activity

    Time frame: Baseline to Day 7/Discharge

  45. Change in Blood High Sensitivity Troponin I

    Time frame: Baseline to Day 7/Discharge

  46. Change in Blood Aldosterone

    Time frame: Baseline to Day 7/Discharge

  47. Change in Blood Procollagen III N-terminal Propepide

    Time frame: Baseline to Day 7/Discharge

  48. Change in Blood Endothelin-1

    Time frame: Baseline to Day 7/Discharge

  49. Change in Blood Carboxy-terminal Telopeptide of Collagen Type I

    Time frame: Baseline to Day 7/Discharge

  50. Change in Blood High Sensitivity C-Reactive Protein

    Time frame: Baseline to Day 7/Discharge

  51. Weight Change

    Time frame: Baseline to Day 30

  52. Change in Furosemide-Equivalent Dose

    Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

    Time frame: Baseline to Day 30

  53. Creatinine Change

    Time frame: Baseline to Day 30

  54. Glomerular Filtration Rate Change

    Time frame: Baseline to Day 30

  55. Weight Change

    Time frame: Baseline to Day 60

  56. Change in Furosemide-Equivalent Dose

    Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

    Time frame: Baseline to Day 60

  57. Best Available Serum Creatinine Change

    Core laboratory when available. If not available, local laboratory results were used.

    Time frame: Baseline to Day 60

  58. Best Available Glomerular Filtration Rate Change

    Core laboratory when available. If not available, local laboratory results were used.

    Time frame: Baseline to Day 60

  59. Change in Blood Uric Acid

    Time frame: Baseline to Day 60

  60. Change in Blood Cystatin C

    Time frame: Baseline to Day 60

  61. Change in Blood N Terminal Pro - B Natriuretic Peptides

    Time frame: Baseline to Day 60

  62. Change in Plasma Renin Activity

    Time frame: Baseline to Day 60

  63. Change in Blood High Sensitivity Troponin I

    Time frame: Baseline to Day 60

  64. Change in Blood Aldosterone

    Time frame: Baseline to Day 60

  65. Change in Blood Procollagen III N-terminal Propepide

    Time frame: Baseline to Day 60

  66. Change in Blood Endothelin-1

    Time frame: Baseline to Day 60

  67. Change in Blood High Sensitivity C-Reactive Protein

    Time frame: Baseline to Day 60

  68. Change in Blood Carboxy-terminal Telopeptide of Collagen Type I

    Time frame: Baseline to Day 60

07

Results

Posted Jun 24, 2013

Participant flow

Participant flow — Overall Study
MilestoneStepped Pharmacologic CareUltrafiltration
Started9494
Completed7372
Not completed2122

Outcome measures

PrimaryChange in Serum Creatinine
Time frame:
Change from Baseline to Day 4
Reported as:
Mean · mg/dL
Change in Serum Creatinine
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Serum Creatinine-0.04 ± 0.530.23 ± 0.70
SecondaryChange in Glomerular Filtration Rate
Time frame:
Change from Baseline to Day 4
Reported as:
Mean · mL/min
Change in Glomerular Filtration Rate
mL/minStepped Pharmacologic CareUltrafiltration
Change in Glomerular Filtration Rate1.67 ± 10.940.93 ± 14.60
SecondaryChange in Serum Creatinine
Time frame:
Change from Baseline to Day 7
Reported as:
Mean · mg/dL
Change in Serum Creatinine
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Serum Creatinine-0.00 ± 0.600.11 ± 0.89
SecondaryChange in Glomerular Filtration Rate
Time frame:
Change from Baseline to Day 7
Reported as:
Mean · mL/min
Change in Glomerular Filtration Rate
mL/minStepped Pharmacologic CareUltrafiltration
Change in Glomerular Filtration Rate2.06 ± 9.321.82 ± 13.84
SecondaryChanges in Weight
Time frame:
Change from Baseline to Day 1
Reported as:
Mean · lbs
Changes in Weight
lbsStepped Pharmacologic CareUltrafiltration
Changes in Weight-3.4 ± 5.2-4.4 ± 4.5
SecondaryChanges in Weight
Time frame:
Change from Baseline to Day 2
Reported as:
Mean · lbs
Changes in Weight
lbsStepped Pharmacologic CareUltrafiltration
Changes in Weight-7.4 ± 8.6-8.8 ± 7.4
SecondaryChange in Weight
Time frame:
Change from Baseline to Day 3
Reported as:
Mean · lbs
Change in Weight
lbsStepped Pharmacologic CareUltrafiltration
Change in Weight-10.8 ± 10.5-11.7 ± 7.7
SecondaryChanges in Weight
Time frame:
Change from Baseline to Day 5
Reported as:
Mean · lbs
Changes in Weight
lbsStepped Pharmacologic CareUltrafiltration
Changes in Weight-15.6 ± 12.0-14.3 ± 10.0
SecondaryChange in Weight
Time frame:
Change from Baseline to Day 6
Reported as:
Mean · lbs
Change in Weight
lbsStepped Pharmacologic CareUltrafiltration
Change in Weight-16.5 ± 15.3-15.7 ± 11.8
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 1
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss1714.1 ± 1400.22193.6 ± 1554.9
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 2
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss3814.2 ± 2384.24705.8 ± 2626.9
PrimaryChange in Weight
Time frame:
Change from Baseline to Day 4
Reported as:
Mean · lbs
Change in Weight
lbsStepped Pharmacologic CareUltrafiltration
Change in Weight-12.1 ± 11.3-12.6 ± 8.5
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 3
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss5706.8 ± 3490.66257.1 ± 3519.7
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 4
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss7081.5 ± 4183.47443.0 ± 4328.7
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 5
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss8358.8 ± 5034.58308.4 ± 5178.1
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 6
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss9700.7 ± 6945.99822.1 ± 6001.7
SecondaryCumulative Net Fluid Loss
Time frame:
Randomization through Day 7
Reported as:
Mean · mL
Cumulative Net Fluid Loss
mLStepped Pharmacologic CareUltrafiltration
Cumulative Net Fluid Loss11659.6 ± 9142.010595.1 ± 7097.4
SecondaryDyspnea Visual Analog Scale

Scale range: -100 , +100 -100=worse, +100=better

Time frame:
Change from Baseline to Day 4
Reported as:
Mean · units on a scale
Dyspnea Visual Analog Scale
units on a scaleStepped Pharmacologic CareUltrafiltration
Dyspnea Visual Analog Scale20.5 ± 27.816.5 ± 29.2
SecondaryChange in Global Visual Analog Scale

Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".

Time frame:
Change from Baseline to Day 4
Reported as:
Mean · units on a scale
Change in Global Visual Analog Scale
units on a scaleStepped Pharmacologic CareUltrafiltration
Change in Global Visual Analog Scale22.8 ± 25.813.7 ± 27.9
SecondaryChange in Dyspnea Visual Analog Scale

Scale range: -100 , +100 -100=worse, +100=better

Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · units on a scale
Change in Dyspnea Visual Analog Scale
units on a scaleStepped Pharmacologic CareUltrafiltration
Change in Dyspnea Visual Analog Scale22.8 ± 27.619.4 ± 31.4
SecondaryChange in Global Visual Analog Scale

Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".

Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · units on a scale
Change in Global Visual Analog Scale
units on a scaleStepped Pharmacologic CareUltrafiltration
Change in Global Visual Analog Scale25.8 ± 30.216.9 ± 29.0
SecondaryChange in Furosemide-Equivalent Dose

Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mg
Change in Furosemide-Equivalent Dose
mgStepped Pharmacologic CareUltrafiltration
Change in Furosemide-Equivalent Dose2.2 ± 166.5-20.6 ± 116.0
SecondaryChange in Blood Sodium Level
Time frame:
Baseline to Day 4
Reported as:
Mean · mEq/L
Change in Blood Sodium Level
mEq/LStepped Pharmacologic CareUltrafiltration
Change in Blood Sodium Level0.00 ± 3.60-2.3 ± 3.51
SecondaryChange in Blood Potassium Level
Time frame:
Baseline to Day 4
Reported as:
Mean · mEq/L
Change in Blood Potassium Level
mEq/LStepped Pharmacologic CareUltrafiltration
Change in Blood Potassium Level-0.23 ± 0.630.26 ± 0.70
SecondaryChange in Blood Urea Nitrogen/Urea
Time frame:
Baseline to Day 4
Reported as:
Mean · mg/dL
Change in Blood Urea Nitrogen/Urea
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Blood Urea Nitrogen/Urea5.68 ± 18.2912.54 ± 24.81
SecondaryChange in Blood Bicarbonate Level
Time frame:
Baseline to Day 4
Reported as:
Mean · mEq/L
Change in Blood Bicarbonate Level
mEq/LStepped Pharmacologic CareUltrafiltration
Change in Blood Bicarbonate Level3.29 ± 3.82-1.01 ± 4.17
SecondaryChange in Blood Hemoglobin Level
Time frame:
Baseline to Day 4
Reported as:
Mean · g/dL
Change in Blood Hemoglobin Level
g/dLStepped Pharmacologic CareUltrafiltration
Change in Blood Hemoglobin Level0.38 ± 0.76-0.01 ± 0.92
SecondaryChange in Blood Sodium Level
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mEq/L
Change in Blood Sodium Level
mEq/LStepped Pharmacologic CareUltrafiltration
Change in Blood Sodium Level-0.49 ± 3.70-2.02 ± 4.11
SecondaryChange in Blood Potassium Level
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mEq/L
Change in Blood Potassium Level
mEq/LStepped Pharmacologic CareUltrafiltration
Change in Blood Potassium Level-0.14 ± 0.600.27 ± 0.75
SecondaryChange in Blood Urea Nitrogen/Urea
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mg/dL
Change in Blood Urea Nitrogen/Urea
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Blood Urea Nitrogen/Urea7.23 ± 20.6913.81 ± 23.91
SecondaryChange in Blood Bicarbonate Level
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mEq/L
Change in Blood Bicarbonate Level
mEq/LStepped Pharmacologic CareUltrafiltration
Change in Blood Bicarbonate Level3.07 ± 4.50-0.70 ± 5.03
SecondaryChange in Blood Hemoglobin Level
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · g/dL
Change in Blood Hemoglobin Level
g/dLStepped Pharmacologic CareUltrafiltration
Change in Blood Hemoglobin Level0.35 ± 0.94-0.02 ± 0.96
SecondaryChange in Blood Cystatin C
Time frame:
Baseline to Day 4
Reported as:
Mean · mg/L
Change in Blood Cystatin C
mg/LStepped Pharmacologic CareUltrafiltration
Change in Blood Cystatin C0.14 ± 0.520.22 ± 0.52
SecondaryChange in Uric Acid
Time frame:
Baseline to Day 4
Reported as:
Mean · mg/dL
Change in Uric Acid
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Uric Acid1.06 ± 1.44-0.23 ± 1.67
SecondaryChange in Blood N- Terminal Pro- BNP
Time frame:
Baseline to Day 4
Reported as:
Mean · pg/mL
Change in Blood N- Terminal Pro- BNP
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood N- Terminal Pro- BNP-978.61 ± 2902.06-814.45 ± 9238.91
SecondaryChange in Plasma Renin Activity
Time frame:
Baseline to Day 4
Reported as:
Mean · ng/mL/hr
Change in Plasma Renin Activity
ng/mL/hrStepped Pharmacologic CareUltrafiltration
Change in Plasma Renin Activity5.78 ± 45.6512.67 ± 31.32
SecondaryChange in Blood High Sensitivity Troponin I
Time frame:
Baseline to Day 4
Reported as:
Mean · pg/mL
Change in Blood High Sensitivity Troponin I
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood High Sensitivity Troponin I47.38 ± 369.85-38.95 ± 1027.37
SecondaryChange in Blood Aldosterone
Time frame:
Baseline to Day 4
Reported as:
Mean · pg/mL
Change in Blood Aldosterone
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood Aldosterone-109.13 ± 489.50-3.07 ± 485.40
SecondaryChange in Blood Procollagen III N-terminal Propepide
Time frame:
Baseline to Day 4
Reported as:
Mean · ug/L
Change in Blood Procollagen III N-terminal Propepide
ug/LStepped Pharmacologic CareUltrafiltration
Change in Blood Procollagen III N-terminal Propepide0.22 ± 4.69-0.64 ± 4.02
SecondaryChange in Blood Endothelin-1
Time frame:
Baseline to Day 4
Reported as:
Mean · pg/mL
Change in Blood Endothelin-1
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood Endothelin-1-0.76 ± 1.70-1.13 ± 3.20
SecondaryChange in Blood High Sensitivity C-Reactive Protein
Time frame:
Baseline to Day 4
Reported as:
Mean · mg/L
Change in Blood High Sensitivity C-Reactive Protein
mg/LStepped Pharmacologic CareUltrafiltration
Change in Blood High Sensitivity C-Reactive Protein-1.71 ± 46.141.89 ± 28.60
SecondaryChange in Blood Carboxy-terminal Telopeptide of Collagen Type I
Time frame:
Baseline to Day 4
Reported as:
Mean · ug/L
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
ug/LStepped Pharmacologic CareUltrafiltration
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I7.63 ± 11.939.07 ± 13.46
SecondaryChange in Blood Cystatin C
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mg/L
Change in Blood Cystatin C
mg/LStepped Pharmacologic CareUltrafiltration
Change in Blood Cystatin C0.12 ± 0.480.09 ± 0.66
SecondaryChange in Blood Uric Acid
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mg/dL
Change in Blood Uric Acid
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Blood Uric Acid1.10 ± 1.85-0.15 ± 2.07
SecondaryChange in Blood N Terminal Pro-Natriuretic Peptide
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · pg/mL
Change in Blood N Terminal Pro-Natriuretic Peptide
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood N Terminal Pro-Natriuretic Peptide-1071.88 ± 3309.45-740.82 ± 8604.86
SecondaryChange in Plasma Renin Activity
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · ng/mL/hr
Change in Plasma Renin Activity
ng/mL/hrStepped Pharmacologic CareUltrafiltration
Change in Plasma Renin Activity2.58 ± 40.7011.40 ± 32.75
SecondaryChange in Blood High Sensitivity Troponin I
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · pg/mL
Change in Blood High Sensitivity Troponin I
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood High Sensitivity Troponin I37.28 ± 350.45-37.16 ± 1231.12
SecondaryChange in Blood Aldosterone
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · pg/mL
Change in Blood Aldosterone
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood Aldosterone-74.26 ± 507.9668.13 ± 624.35
SecondaryChange in Blood Procollagen III N-terminal Propepide
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · ug/L
Change in Blood Procollagen III N-terminal Propepide
ug/LStepped Pharmacologic CareUltrafiltration
Change in Blood Procollagen III N-terminal Propepide-0.07 ± 5.90-0.93 ± 3.54
SecondaryChange in Blood Endothelin-1
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · pg/mL
Change in Blood Endothelin-1
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood Endothelin-1-0.69 ± 1.85-1.24 ± 3.22
SecondaryChange in Blood Carboxy-terminal Telopeptide of Collagen Type I
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · ug/L
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
ug/LStepped Pharmacologic CareUltrafiltration
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I10.21 ± 15.7910.54 ± 15.04
SecondaryChange in Blood High Sensitivity C-Reactive Protein
Time frame:
Baseline to Day 7/Discharge
Reported as:
Mean · mg/L
Change in Blood High Sensitivity C-Reactive Protein
mg/LStepped Pharmacologic CareUltrafiltration
Change in Blood High Sensitivity C-Reactive Protein-6.39 ± 48.562.18 ± 37.72
SecondaryWeight Change
Time frame:
Baseline to Day 30
Reported as:
Mean · lbs
Weight Change
lbsStepped Pharmacologic CareUltrafiltration
Weight Change-15.9 ± 22.4-13.4 ± 21.0
SecondaryChange in Furosemide-Equivalent Dose

Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

Time frame:
Baseline to Day 30
Reported as:
Mean · mg
Change in Furosemide-Equivalent Dose
mgStepped Pharmacologic CareUltrafiltration
Change in Furosemide-Equivalent Dose9.8 ± 188.327.3 ± 120.1
SecondaryCreatinine Change
Time frame:
Baseline to Day 30
Reported as:
Mean · mg/dL
Creatinine Change
mg/dLStepped Pharmacologic CareUltrafiltration
Creatinine Change-0.25 ± 0.68-0.12 ± 0.59
SecondaryGlomerular Filtration Rate Change
Time frame:
Baseline to Day 30
Reported as:
Mean · mL/min
Glomerular Filtration Rate Change
mL/minStepped Pharmacologic CareUltrafiltration
Glomerular Filtration Rate Change7.95 ± 11.856.07 ± 16.13
SecondaryWeight Change
Time frame:
Baseline to Day 60
Reported as:
Mean · lbs
Weight Change
lbsStepped Pharmacologic CareUltrafiltration
Weight Change-17.2 ± 21.1-15.4 ± 23.1
SecondaryChange in Furosemide-Equivalent Dose

Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)

Time frame:
Baseline to Day 60
Reported as:
Mean · mg
Change in Furosemide-Equivalent Dose
mgStepped Pharmacologic CareUltrafiltration
Change in Furosemide-Equivalent Dose-12.4 ± 122.58.8 ± 128.5
SecondaryBest Available Serum Creatinine Change

Core laboratory when available. If not available, local laboratory results were used.

Time frame:
Baseline to Day 60
Reported as:
Mean · mg/dL
Best Available Serum Creatinine Change
mg/dLStepped Pharmacologic CareUltrafiltration
Best Available Serum Creatinine Change-0.28 ± 0.61-0.12 ± 0.67
SecondaryBest Available Glomerular Filtration Rate Change

Core laboratory when available. If not available, local laboratory results were used.

Time frame:
Baseline to Day 60
Reported as:
Mean · mL/min
Best Available Glomerular Filtration Rate Change
mL/minStepped Pharmacologic CareUltrafiltration
Best Available Glomerular Filtration Rate Change8.86 ± 13.265.63 ± 16.49
SecondaryChange in Blood Uric Acid
Time frame:
Baseline to Day 60
Reported as:
Mean · mg/dL
Change in Blood Uric Acid
mg/dLStepped Pharmacologic CareUltrafiltration
Change in Blood Uric Acid-0.31 ± 2.28-0.54 ± 2.60
SecondaryChange in Blood Cystatin C
Time frame:
Baseline to Day 60
Reported as:
Mean · mg/L
Change in Blood Cystatin C
mg/LStepped Pharmacologic CareUltrafiltration
Change in Blood Cystatin C-0.18 ± 0.48-0.03 ± 0.60
SecondaryChange in Blood N Terminal Pro - B Natriuretic Peptides
Time frame:
Baseline to Day 60
Reported as:
Mean · pg/mL
Change in Blood N Terminal Pro - B Natriuretic Peptides
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood N Terminal Pro - B Natriuretic Peptides-490.56 ± 5638.86-937.69 ± 7389.14
SecondaryChange in Plasma Renin Activity
Time frame:
Baseline to Day 60
Reported as:
Mean · ng/mL/hr
Change in Plasma Renin Activity
ng/mL/hrStepped Pharmacologic CareUltrafiltration
Change in Plasma Renin Activity-2.18 ± 41.120.54 ± 20.48
SecondaryChange in Blood High Sensitivity Troponin I
Time frame:
Baseline to Day 60
Reported as:
Mean · pg/mL
Change in Blood High Sensitivity Troponin I
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood High Sensitivity Troponin I-17.48 ± 106.70-73.58 ± 511.98
SecondaryChange in Blood Aldosterone
Time frame:
Baseline to Day 60
Reported as:
Mean · pg/mL
Change in Blood Aldosterone
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood Aldosterone-6.91 ± 672.2140.35 ± 471.50
SecondaryChange in Blood Procollagen III N-terminal Propepide
Time frame:
Baseline to Day 60
Reported as:
Mean · ug/L
Change in Blood Procollagen III N-terminal Propepide
ug/LStepped Pharmacologic CareUltrafiltration
Change in Blood Procollagen III N-terminal Propepide0.75 ± 5.250.58 ± 6.02
SecondaryChange in Blood Endothelin-1
Time frame:
Baseline to Day 60
Reported as:
Mean · pg/mL
Change in Blood Endothelin-1
pg/mLStepped Pharmacologic CareUltrafiltration
Change in Blood Endothelin-1-0.82 ± 1.58-1.32 ± 3.98
SecondaryChange in Blood High Sensitivity C-Reactive Protein
Time frame:
Baseline to Day 60
Reported as:
Mean · mg/L
Change in Blood High Sensitivity C-Reactive Protein
mg/LStepped Pharmacologic CareUltrafiltration
Change in Blood High Sensitivity C-Reactive Protein-13.62 ± 59.581.99 ± 44.92
SecondaryChange in Blood Carboxy-terminal Telopeptide of Collagen Type I
Time frame:
Baseline to Day 60
Reported as:
Mean · ug/L
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
ug/LStepped Pharmacologic CareUltrafiltration
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I2.24 ± 13.444.57 ± 27.84

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stepped Pharmacologic Care—54/94 (57.4%)0/94 (0%)
Ultrafiltration—68/94 (72.3%)0/94 (0%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventStepped Pharmacologic CareUltrafiltration
Cardiac FailureCardiac disorders17/9416/94
Cardiac Failure AcuteCardiac disorders12/9415/94
Renal FailureRenal and urinary disorders11/9410/94
AnaemiaBlood and lymphatic system disorders5/946/94
Renal Failure AcuteRenal and urinary disorders3/946/94
Atrial FibrillationCardiac disorders1/942/94
Cardiac Failure ChronicCardiac disorders0/942/94
HaematuriaRenal and urinary disorders1/942/94
Renal Failure ChronicRenal and urinary disorders2/940/94
Heparin-Induced ThrombocytopeniaBlood and lymphatic system disorders0/941/94

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Stepped Pharmacologic CareUltrafiltrationTotal
<=18 years000
Between 18 and 65 years423577
>=65 years5259111
Age Continuous
Age Continuous(years)Stepped Pharmacologic CareUltrafiltrationTotal
Mean67.1 ± 13.768.9 ± 12.068.0 ± 12.9
Sex: Female, Male
Sex: Female, Male(Participants)Stepped Pharmacologic CareUltrafiltrationTotal
Female262147
Male6873141
08

Study locations

9 sites
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054, United States
  • Morehouse School of Medicine
    Atlanta, Georgia 30310, United States
  • Minnesota Heart Failure Network
    Minneapolis, Minnesota 55415, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • University of Utah Health Sciences Center
    Murray, Utah 84107, United States
  • University of Vermont - Fletcher Allen Health Care
    Burlington, Vermont 05401, United States
  • Montreal Heart Institute
    Montreal, Quebec H1T - 1C8, Canada
09

References and documents

Publications

  • Bart BA, Goldsmith SR, Lee KL, Givertz MM, O'Connor CM, Bull DA, Redfield MM, Deswal A, Rouleau JL, LeWinter MM, Ofili EO, Stevenson LW, Semigran MJ, Felker GM, Chen HH, Hernandez AF, Anstrom KJ, McNulty SE, Velazquez EJ, Ibarra JC, Mascette AM, Braunwald E; Heart Failure Clinical Research Network. Ultrafiltration in decompensated heart failure with cardiorenal syndrome. N Engl J Med. 2012 Dec 13;367(24):2296-304. doi: 10.1056/NEJMoa1210357. Epub 2012 Nov 6. PubMed 23131078 ↗
  • Rao VS, Ahmad T, Brisco-Bacik MA, Bonventre JV, Wilson FP, Siew ED, Felker GM, Anstrom KK, Mahoney DD, Bart BA, Tang WHW, Velazquez EJ, Testani JM. Renal Effects of Intensive Volume Removal in Heart Failure Patients With Preexisting Worsening Renal Function. Circ Heart Fail. 2019 Jun;12(6):e005552. doi: 10.1161/CIRCHEARTFAILURE.118.005552. Epub 2019 Jun 5. PubMed 31163974 ↗
  • Kitai T, Grodin JL, Kim YH, Tang WH. Impact of Ultrafiltration on Serum Sodium Homeostasis and its Clinical Implication in Patients With Acute Heart Failure, Congestion, and Worsening Renal Function. Circ Heart Fail. 2017 Feb;10(2):e003603. doi: 10.1161/CIRCHEARTFAILURE.116.003603. Erratum In: Circ Heart Fail. 2017 Mar;10(3):e000016. doi: 10.1161/HHF.0000000000000016. PubMed 28130379 ↗
  • de Denus S, Rouleau JL, Mann DL, Huggins GS, Cappola TP, Shah SH, Keleti J, Zada YF, Provost S, Bardhadi A, Phillips MS, Normand V, Mongrain I, Dube MP. A pharmacogenetic investigation of intravenous furosemide in decompensated heart failure: a meta-analysis of three clinical trials. Pharmacogenomics J. 2017 Mar;17(2):192-200. doi: 10.1038/tpj.2016.4. Epub 2016 Mar 1. PubMed 26927285 ↗
  • Lala A, McNulty SE, Mentz RJ, Dunlay SM, Vader JM, AbouEzzeddine OF, DeVore AD, Khazanie P, Redfield MM, Goldsmith SR, Bart BA, Anstrom KJ, Felker GM, Hernandez AF, Stevenson LW. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3. PubMed 26041600 ↗
  • Mentz RJ, Stevens SR, DeVore AD, Lala A, Vader JM, AbouEzzeddine OF, Khazanie P, Redfield MM, Stevenson LW, O'Connor CM, Goldsmith SR, Bart BA, Anstrom KJ, Hernandez AF, Braunwald E, Felker GM. Decongestion strategies and renin-angiotensin-aldosterone system activation in acute heart failure. JACC Heart Fail. 2015 Feb;3(2):97-107. doi: 10.1016/j.jchf.2014.09.003. Epub 2014 Oct 31. PubMed 25543972 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00608491
Lead sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Nuwellis, Inc.
Responsible party
Sponsor
First posted
Feb 6, 2008
Start date
Mar 2008
Primary completion
Mar 2012
Completion
Jun 2012
Results posted
Jun 24, 2013
Last update
Jun 24, 2013

Study contacts

Kerry L. Lee, PhD
principal investigator · Duke Clinical Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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