A Phase 1/2 interventional study of Nesiritide and Placebo in Heart Failure and Asymptomatic Systolic Dysfunction, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-17.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Basic science
The following are done for screening procedures to determine if patients are eligible for this study: blood count, kidney and liver blood tests. Patients will complete a 6-minute walk test. Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the study and for the whole duration of the study. Diet instructions will be given to the patient and the patient will collect his/her urine for 24 hours before the active study day. Patients will need to avoid strenuous exercise and abstain from smoking, alcohol, and caffeine for 3 days prior to the study days. Patients will remain on their regular medications.
Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot). The participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks. The study requires a screening visit to determine eligibility and discuss the study. At this visit a blood draw for heart and liver function and a six minute walk will be done. There will also be two other outpatient visits and two inpatient stays, for 48 hours, in the General Clinical Research Center (GCRC) at St. Marys Hospital. During the two in-patient stays in the GCRC, blood and urine samples will be done to get heart and kidney function as well as a research echo. After enrollment, the study lasts for twelve weeks. There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw, 24 hour urine collection and resupply the study medication. There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw, 24 hour urine collection and resupply the study medication.
146 studies on the registry are indexed under Systolic Murmurs; 17 are open to participants now.
This study's enrollment of 37 is below the median of 93 across 87 interventional studies indexed under Systolic Murmurs.
Browse Systolic Murmurs studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is \>90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Drug: Nesiritide
Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Drug: Placebo
Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is \>90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Also known as: Natrecor, Human B-type natriuretic peptide (BNP)
Normal saline will be used for placebo.
Change in Urinary Sodium Excretion in Response to Saline Load
Time frame: baseline, 12 weeks
Change in Urine Flow in Response to Saline Load
Time frame: baseline, 12 weeks
Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load
Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m\^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m\^2 of body surface area is considered to be impaired kidney function.
Time frame: baseline, 12 weeks
Change in Left Ventricular Mass Index
Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.
Time frame: baseline, 12 weeks
All subjects were recruited from the Mayo Clinic in Rochester, Minnesota.
| Milestone | Nesiritide | Placebo |
|---|---|---|
| Started | 25 | 12 |
| Completed | 22 | 12 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Seizure prior to receiving bnp | 1 | 0 |
| ml/min | Nesiritide | Placebo |
|---|---|---|
| Change in Urine Flow in Response to Saline Load | 3.1 ± 3.8 | -0.4 ± 2.1 |
Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m\^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m\^2 of body surface area is considered to be impaired kidney function.
| ml/min/1.73 m^2 | Nesiritide | Placebo |
|---|---|---|
| Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load | 1.6 ± 9.7 | -7.4 ± 12.5 |
Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.
| g/m^2 | Nesiritide | Placebo |
|---|---|---|
| Change in Left Ventricular Mass Index | -5.8 ± 15.7 | 2.0 ± 5.4 |
| mEq/min | Nesiritide | Placebo |
|---|---|---|
| Change in Urinary Sodium Excretion in Response to Saline Load | 179.1 ± 252.2 | 3.1 ± 102.4 |
Collected over Subjects will be followed for the 12 weeks while on study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nesiritide | — | 0/22 (0%) | 10/22 (45.5%) |
| Placebo | — | 0/12 (0%) | 4/12 (33.3%) |
| Event | Nesiritide | Placebo |
|---|---|---|
| HypotensionInvestigations | 6/22 | 1/12 |
| Heart Failure symptomsCardiac disorders | 2/22 | 0/12 |
| TachycardiaCardiac disorders | 2/22 | 0/12 |
| Blurring VisionEye disorders | 0/22 | 1/12 |
| HyperkalemiaVascular disorders | 1/22 | 1/12 |
| ThromboembolismVascular disorders | 0/22 | 1/12 |
| Urinary Tract InfectionRenal and urinary disorders | 0/22 | 1/12 |
| Flank painNervous system disorders | 1/22 | 0/12 |
| GoutGeneral disorders | 1/22 | 0/12 |
| HospitalizationGeneral disorders | 1/22 | 0/12 |
| Age, Categorical(Participants) | Nesiritide | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 8 | 19 |
| >=65 years | 14 | 4 | 18 |
| Sex: Female, Male(Participants) | Nesiritide | Placebo | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 22 | 10 | 32 |
| Region of Enrollment(participants) | Nesiritide | Placebo | Total |
|---|---|---|---|
| United States | 25 | 12 | 37 |
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