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

Mayo Clinic41 enrolled

Overview

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.

Prior to initiation of the study, subjects will be stabilized for at least one week on a no added salt diet (120 milliequivalent (mEq) Na/Day) which will be maintained during the study. 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 Clinical Research Unit at St. Marys Hospital. During the two overnight stays, blood and urine samples will be done to get heart and kidney function as well as a research echocardiogram. An acute saline load (0.9% normal saline 1.25 ml/kg/min for 1 hour) will be given and blood and urine samples collected After enrollment, the study lasts for twelve weeks. It is planned to treat 2 subjects with active drug per each placebo subject to improved the precision of between group comparison.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Left Ventricular Diastolic Dysfunction

Interventions

BNP (nesiritide)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \< 125 mEq/dL or \> 160 mEq/dL (milliequivalents per deciliter) * Serum potassium of \< 3.5 mEq/dL or \> 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)

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Urinary Sodium Excretion in Response to Saline Load

Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).

Time frame: Baseline, 12 weeks

Secondary Outcomes

Change in Urinary Flow in Response to Saline Load

Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.

Time frame: Baseline, 12 weeks

Change in Glomerular Filtration Rate (GFR) in Response to Saline Load

Renal or 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/ml/1.73 m\^2 of body surface area is considered to be impaired kidney function.

Time frame: Baseline, 12 weeks

Left Ventricular (LV) Filling Pressure

LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.

Time frame: Baseline, 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.