Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test BNP (Nesiritide).

It had two arms (groups): Tadalafil plus Placebo, then Tadalafil plus Nesiritide (experimental) and Tadalafil plus Nesiritide, then Tadalafil plus Placebo (experimental).

The registry classes the interventions as drug.

More on the Plan

Cyclic guanosine monophosphate (cGMP) is the second messenger of the natriuretic peptide system (NPS) and the nitric oxide system (NO) and plays an important role in the preservation of myocardial, vascular, and renal function.

Hence, disruption of this signal transduction process may contribute to the development of cardiorenal dysfunction.

PDEV inhibitors are FDA approved for erectile dysfunction and pulmonary hypertension.

Who Took Part

The registry lists 43 actual participants took part.

It was open to people of any sex aged from 21 years up to 90 years.

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

Examples of who could join: A minimal distance on 6-minute walk of \>450 meters. A 6-minute walk distance of 450 meters. Minimal distance on 6-minute walk of \>450 meters.

The full record lists 8 inclusion and 26 exclusion criteria; among the exclusions: current or anticipated future need for nitrate therapy; patients taking alpha antagonists or cytochrome p450 3a4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum protease inhibitors for hiv); patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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

Each person switched between BNP (Nesiritide) and the comparison at some point, usually with a gap in between.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-02 with completion listed for 2013-08.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 43 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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