Rationale, design, and methods for the Transplant-Eligible MAnagement of Congestive Heart Failure (TMAC) trial: a multicenter clinical outcomes trial using nesiritide for TMAC

What Was Tested

This randomized controlled trial paper looks at BNP (Nesiritide).

Urgent heart transplant candidates classified as United Network for Organ Sharing status 1B who require continuous infusions of inotropic agents for hemodynamic stability often have hemodynamic, electrical, or multisystem decompensation.

Who Took Part

TMAC is a prospective, randomized, parallel, multicenter, double-blind, placebo-controlled study in patients awaiting heart transplantation who meet United Network for Organ Sharing status 1B criteria (N = 120) and receive continuous dobutamine or milrinone through a double-lumen central catheter for at least 3 consecutive days before randomization.

Patients will receive standard care and continuous intravenous inotrope therapy plus a 28-day continuous infusion of nesiritide or placebo.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled, multicenter and parallel-group.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

Some participants received a placebo instead of BNP (Nesiritide), giving a reference point.

More than one site took part, so the participants came from several places.

A time span of 6 months appears in the methods.

There will be up to 6 months of follow-up.

Secondary analyses will evaluate effects on hemodynamics, echocardiographic parameters, endogenous brain-type natriuretic peptide levels, modification of diet in renal disease-calculated glomerular filtration rate, and all-cause and cardiovascular mortality.

Two mechanistic substudies will evaluate the effect on iohexol-determined glomerular filtration rate and assess changes in lung mechanics.

What Was Measured

Topics PubMed links to this paper include Cardiotonic Agents, Dobutamine, Echocardiography, Eligibility Determination, Heart Failure, Heart Transplantation and Natriuretic Agents.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of BNP (Nesiritide) over 6 months.

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (American heart journal), a journal based in United States.

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