Evaluation of Combined Action Between Natrecor and Furosemide on Kidney and Neurohormone Responses in Chronic Heart Failure: A Phase-IV study704.351 / DSS

What Was Tested

The trial (phase 4) is built around BNP (Nesiritide).

This is a randomized, open-label, three-way crossover design study with 3 treatment groups:TREATMENT A: Furosemide;TREATMENT B: Nesiritide administered IV bolus, followed by an infusion for 6 hours;TREATMENT C: Treatment B for at least 15 minutes, then administration of treatment AAll sequences involving both furosemide and nesiritide had the nesiritide infusion started first, at least 15 minutes before furosemide was administered.

Each treatment will be administered according to 1 of 6 sequences to which patients are randomized.

Patients will remain in the Clinical Research Unit for 7 days, with treatments administered on Days 2, 4, and 6, with equilibrium (rest) days on Days 1, 3, and 5.

The registry classes the interventions as drug.

More on the Plan

Nesiritide is the recombinant form of human B-type natriuretic peptide (hBNP).

Furosemide (Lasix) is frequently administered to patients with acutely decompensated heart failure to relieve pulmonary vascular congestion and promote diuresis.

Therefore, nesiritide may inhibit the anti-natriuretic effect of angiotensin II and aldosterone on proximal and distal tubules of the kidney.

Given the contrasting properties of furosemide and nesiritide on neuroendocrine activation in the setting of heart failure, the combination of these agents may be synergistic.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Chronic symptomatic NYHA Class II or III CHF for at least 90 days before the study. Serum potassium \> 3.5 mEq/L. Receiving a stable medical regimen for CHF for at least 60 days before the study start, including angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARBs), and/or beta-blockers.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: systolic blood pressure (sbp) consistently \< 90 mm hg; myocardial infarction within 90 days of study start, unstable angina within 14 days of study start, or any clinical evidence of active myocardial ischemia; percutaneous coronary intervention or cardiac surgery within 90 days of study start.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both BNP (Nesiritide) and the comparison in turn, acting as their own control.

Everyone knew when BNP (Nesiritide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-03 with completion listed for 2004-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Patient's urinary excretion rate of sodium.

It also tracked 1 secondary outcome, for example Patient's urinary flow rate, urinary excretion of potassium, calcium and magnesium, and urinary excretion of cGMP and furosemide.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, all human trials.