Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC

What Was Tested

This registered phase 2 trial tested BNP (Nesiritide).

It had two arms (groups): 001 (experimental) and 002 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

However, normal biologic compensatory responsiveness to BNP is attenuated in patients with severe HF.

Patients who are UNOS 1B cardiac transplant candidates have relatively few options for therapy, despite the fact that they constitute a very ill patient population.

These options include getting a transplant, if one is available, receiving intravenous inotropes and/or vasodilators, or being implanted with a circulatory support device (e.g.

Natrecor (Nesiritide) is a human recombinant form of BNP approved for use in the treatment of acute decompensated HF.

Who Took Part

16 actual participants 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: Meet the criteria for a United Network for Organ Sharing (UNOS) Status 1B heart transplant candidate, or, if outside the US, have comparable status. Must also be a primary transplant candidate waiting to receive a single cardiac allograft. Must be receiving continuous intravenous infusion of dobutamine or milrinone through a double-lumen central catheter or a double-lumen percutaneously inserted central catheter for at least 3 consecutive days before randomization. Must be willing and able to participate in the study assessments and follow up procedures.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: not weigh \> 130 kg; not have a ventricular assist device (vad), or anticipate the need for a vad, during the 28-day study drug treatment period; not have received placement of an internal cardiac defibrillator (icd) or external cardiac defibrillator (ecd) within 72 hours before randomization.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received BNP (Nesiritide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2006-09 with completion listed for 2007-10.

It ran at 14 sites in United States (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment) (time frame: 28 days).

It also tracked 3 secondary outcomes, for example Changes in Pulmonary Capillary Wedge Pressure (PCWP), All Cause Mortality and Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 16 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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