A Phase 1/2 interventional study of B-type Natriuretic Peptide (BNP) and Placebo in Congestive Heart Failure and Cardiomyopathy, sponsored by Horng Chen. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-20.
Sponsored by Horng Chen · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the effects of subcutaneous injection of Human BNP (nesiritide), a hormone produced by the heart, on the pumping ability of the heart, kidney function, and hormonal function in persons with heart failure.
The cardiac hormone brain natriuretic peptide (BNP) plays an important role in the pathophysiology of congestive heart failure (CHF). Studies have established that BNP mediates natriuresis, renin and aldosterone (RAAS) inhibition, vasodilation and lusitropism. Acute cardiac hormone replacement with intravenous infusion of BNP has been shown to possess potent vasodilating actions in humans with acute decompensated CHF resulting in improvement of clinical symptoms. Natrecor (nesiritide) a sterile, purified preparation of human BNP is approved by the FDA for intravenous administration in the treatment of patients with acute decompensated congestive heart failure. However, chronic cardiac hormone replacement with BNP as therapeutic strategy in CHF has been limited by the need to administer BNP intravenously. The objective of this study is to define the cardiorenal and humoral actions of short term (eight weeks) chronic cardiac hormone replacement with subcutaneous (SQ) BNP in human NYHA class II-III CHF. Systolic and diastolic function, left ventricular remodeling as assessed by its volume, renal function, neurohumoral profiling and exercise capacity will be assessed prior to and after eight weeks of treatment.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 45 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
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BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
Drug: B-type Natriuretic Peptide (BNP)
Placebo self-administered subcutaneously twice daily for 8 weeks.
Other: Placebo
BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
Also known as: Nesiritide
Placebo self-administered subcutaneously twice daily for 8 weeks.
Change in Left Ventricular (LV) Volume Index at 8 Weeks
LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.
Time frame: Baseline and 8 weeks
Change in Left Ventricular (LV) Mass Index at 8 Weeks
Time frame: Baseline and 8 weeks
Change in Left Ventricular (LV) Filling Pressure at 8 Weeks
Filling pressure determined by ratio of E/e' \[Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio\]
Time frame: Baseline and 8 weeks
Change in Plasma Renin Activity at 8 Weeks
Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.
Time frame: Baseline and 8 weeks
Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks
Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate 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.
Time frame: Baseline and 8 weeks
Change in Heart Rate at 8 Weeks
Heart rate was measured when MRI was performed
Time frame: Baseline and 8 weeks
Change in Blood Pressure at 8 Weeks
Blood pressure was measured during the MRI
Time frame: Baseline and 8 weeks
Change in Left Ventricular Ejection Fraction at 8 Weeks
Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).
Time frame: Baseline and 8 weeks
Participants were recruited from May 2003 to May 2008 at the Mayo Clinic in Rochester, Minnesota.
| Milestone | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Started | 24 | 21 |
| Completed | 20 | 20 |
| Not completed | 4 | 1 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.
| ml/m^2 | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| End-systolic LV volume index | -5.2 ± 13 | 5.8 ± 9.6 |
| End-diastolic LV volume index | -10.0 ± 15.4 | 6.1 ± 12.4 |
Filling pressure determined by ratio of E/e' \[Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio\]
| E/e' | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in Left Ventricular (LV) Filling Pressure at 8 Weeks | -2.3 ± 2.5 | 1.1 ± 3.1 |
Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.
| nanograms per milliliter per hour | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in Plasma Renin Activity at 8 Weeks | -3.5 ± 7.1 | 2.3 ± 4.8 |
Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate 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.
| ml/min/1.73 m^2 of body-surface area | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks | 6.9 ± 14.2 | -2.8 ± 24.8 |
| mg/m^2 | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in Left Ventricular (LV) Mass Index at 8 Weeks | -4.4 ± 9.8 | 6.2 ± 12.9 |
Heart rate was measured when MRI was performed
| beats per minute | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in Heart Rate at 8 Weeks | -1.6 ± 8.3 | -0.9 ± 7.2 |
Blood pressure was measured during the MRI
| mmHg | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in systolic blood pressure | -4.9 ± 22.2 | 4.5 ± 17.7 |
| Change in diastolic blood pressure | -2.4 ± 8.5 | 0.9 ± 12.1 |
Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).
| percentage | B-type Natriuretic Peptide (BNP) | Placebo |
|---|---|---|
| Change in Left Ventricular Ejection Fraction at 8 Weeks | 0.0 ± 7.5 | -1.1 ± 4.2 |
Collected over Adverse events were collected over the 8 week study period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BPN Group | — | 3/24 (12.5%) | 20/24 (83.3%) |
| Placebo | — | 1/21 (4.8%) | 17/21 (81%) |
| Event | BPN Group | Placebo |
|---|---|---|
| worsening heart failure symptomsCardiac disorders | 0/24 | 1/21 |
| hypotensionCardiac disorders | 1/24 | 0/21 |
| lightheadednessCardiac disorders | 1/24 | 0/21 |
| visual disturbancesEye disorders | 1/24 | 0/21 |
| Event | BPN Group | Placebo |
|---|---|---|
| Shortness of Breath and FatigueCardiac disorders | 3/20 | 7/20 |
| Injection site sting/itchySkin and subcutaneous tissue disorders | 4/20 | 3/20 |
| LightheadednessCardiac disorders | 3/20 | 0/20 |
| FlushingBlood and lymphatic system disorders | 3/20 | 1/20 |
| Flu-like symptomsGeneral disorders | 1/20 | 2/20 |
| Loose stoolsGastrointestinal disorders | 2/20 | 0/20 |
| Atrial FibrillationCardiac disorders | 0/20 | 1/20 |
| HyperkalemiaMetabolism and nutrition disorders | 1/20 | 1/20 |
| EdemaBlood and lymphatic system disorders | 1/20 | 0/20 |
| GI bleed prior to study drug administrationGastrointestinal disorders | 1/20 | 0/20 |
| Age, Categorical(Participants) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 22 |
| >=65 years | 13 | 10 | 23 |
| Age Continuous(years) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| Mean | 66 ± 10 | 65 ± 11 | 66 ± 11 |
| Sex: Female, Male(Participants) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| Female | 4 | 8 | 12 |
| Male | 20 | 13 | 33 |
| Region of Enrollment(participants) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| United States | 24 | 21 | 45 |
| Blood pressure(mmHg) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| Systolic blood pressure | 131 ± 18 | 127 ± 17 | 129 ± 17 |
| Diastolic blood pressure | 72 ± 11 | 72 ± 14 | 72 ± 12 |
| New York Heart Association (NYHA) CHF Classification(participants) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| NYHA CHF Class II | 13 | 10 | 23 |
| NYHA CHF Class III | 2 | 1 | 3 |
| Left Ventricle Ejection Fraction (Echo)(Percentage) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| Mean | 32 ± 9 | 31 ± 7 | 31 ± 8 |
| Heart Rate(beats per minute) | B-type Natriuretic Peptide (BNP) | Placebo | Total |
|---|---|---|---|
| Mean | 65 ± 13 | 68 ± 12 | 67 ± 13 |
4 further baseline measures are reported on the registry.
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nesiritide
Horng Chen