The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure

What Was Tested

This registered phase 4 trial tested ANP (Atrial Natriuretic Peptide).

However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure.

The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.

It had two arms (groups): Standard Therapy (placebo comparator) and Carperitide Therapy (active comparator).

Standard heart failure therapy excluding carperitide administration.

Addition of carperitide administration to standard heart failure therapy.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Heart failure of any etiology, diagnosed according to Framingham criteria.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: severe heart failure required percutaneous cardiopulmonary bypass support (pcps); end-stage renal failure on maintenance dialysis; severe hepatic dysfunction.

How the Study Was Run

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

The participants were allocated by chance, so the ANP (Atrial Natriuretic Peptide) group and the comparison group should start out alike.

The ANP (Atrial Natriuretic Peptide) group and the comparison group ran side by side rather than switching.

In this single-blind ANP (Atrial Natriuretic Peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2009-05 with completion listed for 2013-05.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Unexpected rehospitalization for cardiovascular events, uremic symptom, initiation of maintenance dialysis, and kidney transplantation (time frame: at 6 months and 2 years).

It also tracked 5 secondary outcomes, for example All cause mortality, Plasma B-type natriuretic peptide concentration and Estimated GFR.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ANP (Atrial Natriuretic Peptide) in 200 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ANP (Atrial Natriuretic Peptide) compound page, all human trials.