Nesiritide and Renal Function After the Total Artificial Heart

What Was Tested

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

The prevalence of renal dysfunction after implantation of the artificial heart is high.

The renal protective and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared to heart failure surgery that leaves the native myocardium intact.

It had four arms (groups): Total Artificial Heart (experimental), Total Artificial Heart: Placebo (placebo comparator), LVAD: Nesiritide (active comparator) and LVAD: Placebo (placebo comparator).

Nesiritide.

Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo.

Active arm of the LVAD group.

The registry classes the interventions as drug.

More on the Plan

This study will enroll 20 adult patients who have undergone implantation of a circulatory support device (10 TAH patients, 10 Left ventricular assist device (LVAD) patients).

Patients will receive standard postoperative care, including anticoagulation, continuous hemodynamic monitoring with an arterial line and central venous line and hemodynamic support as determine by the cardiac surgery clinical team.

The researchers will exclude patients who are receiving renal replacement therapy at the time of device implantation or those that have had previous solid organ transplantation in order to remove the confounding influence of calcineurin inhibitor exposure on renal function.

Patient unable to provide informed consent will also be excluded.

Who Took Part

Enrollment: 2 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: Implanted with a total artificial heart (CardioWest) or Left ventricular assist device (HeartMate II). Age \> 18 years.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: previous calcineurin inhibitor (cni) exposure; hemodialysis prior to device implant.

How the Study Was Run

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

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.

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 2013-04 with completion listed for 2014-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glomerular Filtration Rate (time frame: 46 hours). Renal Plasma Flow (time frame: 46 Hours).

It also tracked 4 secondary outcomes, for example Need for Hemodialysis/Renal Replacement Therapy, Urine Output, Time to Renal Failure and Total Diuretic Requirement.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 2 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.