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CompletedNCT00279955Updated Jun 15, 2012Results posted

PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

An observational study in Heart Failure, Congestive, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 93 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-15.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,024
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.

02

Conditions studied

  • Heart Failure, Congestive

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Keywords

  • Heart Failure, Congestive
  • Implantable Cardioverter-Defibrillators
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 1,024 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) 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
Sampling method
Non-probability sample

Study population

Patients receiving a specified Medtronic Implantable Cardiac Resynchronization Therapy Defibrillator device where informed consent and/or authorization to use and disclose health information permission has been granted.

Inclusion criteria

  • Patients who meet the ICD indications
  • Patients with Class III or IV heart failure.
  • Patients receiving or who received a Medtronic CRT ICD within the previous 3 months.
  • Patient must sign and date informed consent, and be 18 years of age or greater.
  • Patient must be available for follow up visits, and be willing and able to comply with study protocol.

Exclusion criteria

Exclusion Criteria:

  • Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month.
  • Patient with a mechanical right heart valve.
  • Patient with chronic (permanent) atrial arrhythmias.
  • Patient with life expectancy of less than 12 months.
  • Patient with status post heart transplant
  • Patient undergoing kidney dialysis
  • Patients enrolled in a concurrent study that may confound the results of the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,024 participants (actual)

Interventions

  • DeviceCardiac Resynchronization Therapy Device

    Patients with an ICD indication, a CRT indication and symptomatic heart failure who are implanted with a Cardiac Resynchronization Therapy Device.

06

What researchers measure

Primary outcomes

  1. Occurrence of Heart Failure (HF) Related Adverse Event (AE)

    Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.

    Time frame: From 6 month to the 12 month visit

Secondary outcomes

  1. Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)

    Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.

    Time frame: 6 month to the 12 month visit

  2. Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)

    Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.

    Time frame: 6 month to the 12 month visit

07

Results

Posted Dec 8, 2011

Participant flow

1024 subjects were enrolled in the study from 21 JUN 2004 through 14 FEB 2007 from 100 centers in US. Follow-up data collection ended on 06 MAR 2008.

Participant flow — Overall Study
MilestoneAt Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREPNo OptiVol Measurement
Started157486358
Completed157486358
Not completed000

Outcome measures

PrimaryOccurrence of Heart Failure (HF) Related Adverse Event (AE)

Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.

Time frame:
From 6 month to the 12 month visit
Reported as:
Number · participants
Occurrence of Heart Failure (HF) Related Adverse Event (AE)
participantsAt Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREP
Occurrence of Heart Failure (HF) Related Adverse Event (AE)2950
Statistical analysis
  • At Least 1 OptiVol Fluid Index > 100 During DREP vs No OptiVol Fluid Index > 100 During DREP · Regression, Cox · p = 0.0119 · Cox proportional hazard: 2.07 · 95% CI 1.17 to 3.67The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.
SecondaryOccurrence of Heart Failure (HF) Related Healthcare Utilization (HU)

Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.

Time frame:
6 month to the 12 month visit
Reported as:
Number · participants
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)
participantsAt Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREP
Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)2235
Statistical analysis
  • At Least 1 OptiVol Fluid Index > 100 During DREP vs No OptiVol Fluid Index > 100 During DREP · Regression, Cox · p = 0.0185 · Cox proportional hazard: 1.90 · 95% CI 1.11 to 3.27The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing \<90% in last 21 days of DREP.
SecondaryOccurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)

Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.

Time frame:
6 month to the 12 month visit
Reported as:
Number · participants
Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)
participantsAt Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREP
Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)1728
Statistical analysis
  • At Least 1 OptiVol Fluid Index > 100 During DREP vs No OptiVol Fluid Index > 100 During DREP · Regression, Cox · p = 0.0578 · Hazard ratio (hr): 1.80 · 95% CI 0.98 to 3.31A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.

Adverse events

Collected over Those adverse events were collected during the study (0 to 12 month follow-up).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
At Least 1 OptiVol Fluid Index > 100 During DREP—84/157 (53.5%)75/157 (47.8%)
No OptiVol Fluid Index > 100 During DREP—114/486 (23.5%)172/486 (35.4%)
No OptiVol Measurement—99/358 (27.7%)96/358 (26.8%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventAt Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREPNo OptiVol Measurement
Heart failure decompensationGeneral disorders24/15722/48624/358
zAll "Other" codesGeneral disorders23/15713/48619/358
Dyspnea/Shortness of breathGeneral disorders12/15721/48618/358
Ventricular tachycardiaGeneral disorders5/1578/4862/358
Atrial fibrillationGeneral disorders2/15710/4864/358
HypotensionGeneral disorders3/1574/4861/358
Pulmonary embolismGeneral disorders2/1571/4862/358
Peripheral edemaGeneral disorders0/1570/4864/358
Atrial flutterGeneral disorders1/1575/4861/358
Chest pressure/tightnessGeneral disorders0/1573/4863/358
Most frequent other events
Showing 10 of 32
Most frequent other events
EventAt Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREPNo OptiVol Measurement
Dyspnea/Shortness of breathGeneral disorders23/15739/48619/358
zAll "Other" CodesGeneral disorders12/15717/48612/358
Heart failure decompensationGeneral disorders6/1578/4864/358
Peripheral edemaGeneral disorders6/15716/48610/358
Fatigue, tirednessGeneral disorders3/15716/4863/358
DizzinessGeneral disorders4/15712/4864/358
Atrial fibrillationGeneral disorders3/1576/4866/358
HypotensionGeneral disorders3/1572/4864/358
Ventricular tachycardiaGeneral disorders2/1573/4866/358
yOther Patient Disease/Conduction CodesGeneral disorders1/1578/4864/358

Baseline characteristics

Age Continuous
Age Continuous(years)At Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREPNo OptiVol MeasurementTotal
Mean68.8 ± 11.068.2 ± 10.668.5 ± 11.068.4 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)At Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREPNo OptiVol MeasurementTotal
Female45163109317
Male112323249684
Region of Enrollment
Region of Enrollment(participants)At Least 1 OptiVol Fluid Index > 100 During DREPNo OptiVol Fluid Index > 100 During DREPNo OptiVol MeasurementTotal
United States1574863581001
08

Study locations

93 sites
  • Huntsville, Alabama, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Little Rock, Arkansas, United States
  • Loma Linda, California, United States
  • San Diego, California, United States
  • Denver, Colorado, United States
  • Guilford, Connecticut, United States
  • Bradenton, Florida, United States
  • Ft. Lauderdale, Florida, United States
  • Key Largo, Florida, United States
  • Melbourne, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Palm Beach Gardens, Florida, United States
  • Pensacola, Florida, United States
  • Safety Harbor, Florida, United States
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Honolulu, Hawaii, United States
  • Evanston, Illinois, United States
  • Maywood, Illinois, United States
  • Merrionette Park, Illinois, United States
  • Rockford, Illinois, United States
  • Springfield, Illinois, United States
  • Winfield, Illinois, United States
  • Topeka, Kansas, United States
  • Wichita, Kansas, United States
  • Edgewood, Kentucky, United States
  • Florence, Kentucky, United States
  • Louisville, Kentucky, United States
  • Covington, Louisiana, United States
  • Monroe, Louisiana, United States
  • Portland, Maine, United States
  • Salisbury, Maryland, United States
  • Takoma Park, Maryland, United States
  • Grand Rapids, Michigan, United States
  • Marquette, Michigan, United States
  • Petoskey, Michigan, United States
  • Traverse City, Michigan, United States
  • Minneapolis, Minnesota, United States
  • St. Cloud, Minnesota, United States
  • St. Louis, Missouri, United States
  • Missoula, Montana, United States
  • Las Vegas, Nevada, United States
  • Manchester, New Hampshire, United States
  • Cherryhill, New Jersey, United States
  • Ridgewood, New Jersey, United States
  • Sewell, New Jersey, United States
  • Bronx, New York, United States
  • New York, New York, United States
  • West Islip, New York, United States
  • Williamsville, New York, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Bismarck, North Dakota, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Dayton, Ohio, United States
  • Elyria, Ohio, United States
  • Lakewood, Ohio, United States
  • Mayfield Heights, Ohio, United States
  • West Lake, Ohio, United States
  • Medford, Oregon, United States
  • Camp Hill, Pennsylvania, United States
  • Erie, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Wormleysburg, Pennsylvania, United States
  • York, Pennsylvania, United States
  • Pawtucket, Rhode Island, United States
  • Providence, Rhode Island, United States
  • Columbia, South Carolina, United States
  • Spartanburg, South Carolina, United States
  • Sioux Falls, South Dakota, United States
  • Knoxville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Fairfax, Texas, United States
  • Fort Worth, Texas, United States
  • Lubbock, Texas, United States
  • Burlington, Vermont, United States
  • Lynchburg, Virginia, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Kirkland, Washington, United States
  • Green Bay, Wisconsin, United States
  • Madison, Wisconsin, United States
09

References and documents

Publications

  • Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O'Connor CM; PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol. 2010 Apr 27;55(17):1803-10. doi: 10.1016/j.jacc.2009.11.089. PubMed 20413029 ↗
  • Whellan DJ, O'Connor CM, Ousdigian KT, Lung TH; PARTNERS HF Study Investigators. Rationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF). Am Heart J. 2008 Nov;156(5):833-9, 839.e2. doi: 10.1016/j.ahj.2008.06.036. Epub 2008 Sep 23. PubMed 19061695 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00279955
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
Responsible party
Sponsor
First posted
Jan 20, 2006
Start date
Jun 2004
Primary completion
Mar 2008
Completion
Jun 2008
Results posted
Dec 8, 2011
Last update
Jun 15, 2012

Study contacts

David Whellan, MD
principal investigator · Jefferson Heart Institute
View the source record on ClinicalTrials.gov ↗

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