Phase 2 N=41 Randomized Triple-blind Basic Science

Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.

Left Ventricular Diastolic Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT00405548 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Change in Urinary Sodium Excretion in Response to Saline Load — 381.6; -10.5 mEq/minute — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BNP (nesiritide) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Urinary Sodium Excretion in Response to Saline Load	381.6; -10.5	<0.001 sig
SECONDARY Change in Urinary Flow in Response to Saline Load	4.2; -1.0	<0.001 sig
SECONDARY Change in Glomerular Filtration Rate (GFR) in Response to Saline Load	6.8; 4.4	0.05
SECONDARY Left Ventricular (LV) Filling Pressure	14.9; 14.9; 12.6; 14.0	0.004 sig

Summary

The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood in response to an intravenous salt solution.

Eligibility Criteria

Inclusion Criteria

Subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography
No signs or symptoms of congestive heart failure and who have not been hospitalized for heart failure

Exclusion criteria

Myocardial Infarction (MI) within 3 months of screening
Unstable angina within 14 days of screening, or any evidence of myocardial ischemia
Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
Severe congenital heart diseases
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Second or third degree heart block without a permanent cardiac pacemaker
Stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion
Total bilirubin of > 1.5 mg/dL or other liver enzymes > 1.5 times the upper limit of normal (mg/dL = milligrams per deciliter)
Serum creatinine of > 3.0 mg/dL
Serum sodium of 160 mEq/dL (milliequivalents per deciliter)
Serum potassium of 5.0/dL
Serum digoxin level of > 2.0 ng/ml (nanograms per milliliter)
Systolic pressure of < 85 mm Hg (millimeters of mercury)
Hemoglobin < 10 gm/dl (grams per deciliter)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00405548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.