Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

What Was Tested

In this phase 2 trial, researchers set out to test Relaxin (Serelaxin).

This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure.

In addition safety and effects on renal function and biomarkers will be assessed.

It had two arms (groups): RLX030 (experimental) and Placebo (placebo comparator).

RLX030 as intravenous infusion for 24 hours.

Placebo as intravenous infusion for 24 hours.

The registry classes the interventions as drug.

Who Took Part

118 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: Written informed consent must be obtained before any assessment is performed. Mild to moderate renal impairment.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: systolic blood pressure (sbp) \< 110 mm hg at the time of randomization; administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization; current use of non-steroidal antiinflammatory drugs (nsaids).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Relaxin (Serelaxin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2012-02 with completion listed for 2012-12.

It ran at 15 sites in Poland (7), Germany (4), Netherlands (3) and United States (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in renal plasma flow (RPF) measured by Para-aminohippuric acid (PAH) clearance in subjects with CHF after 24 hours intravenous (i.v) infusion of RLX030 (time frame: Baseline, during and after the end of 24 hours infusion). Change from baseline in glomerular filtration rate (GFR) as measured by Iothalamate (IOTH) clearance in subjects with CHF after 24 hours i.v. infusion of RLX030 (time frame: Baseline, during and after the end of 24 hours infusion).

It also tracked 15 secondary outcomes, for example Change from baseline in filtration fraction (FF) in subjects with CHF after 24 hours infusion of RLX030, Change over time in Diuresis, Change over time in calculated creatinine clearance, Change over time on fractional sodium excretion(natriuresis), Central aortic systolic pressure-time curve and Radial augmentation index-time curve.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 118 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Relaxin (Serelaxin) compound page, all human trials.