Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure

What Was Tested

The trial (phase 2) is built around Relaxin (Serelaxin).

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.

It had two arms (groups): Serelaxin followed by Placebo (experimental) and Placebo followed by Serelaxin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 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: Male or female ≥ 18 years of age, with body weight ≤ 160 Kg. Diagnosis of stable CHF:. New York Heart Association (NYHA) functional Class II/III. Receiving guideline-recommended treatment for CHF. NT-proBNP \> 300 ng/L in sinus rhythm or \> 900 ng/L if not in sinus rhythm (determined locally).

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: dyspnea primarily due to non-cardiac causes; any contraindication for exercise testing and spirometry; change in guideline-recommended chf treatment within 1 month prior to screening.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Relaxin (Serelaxin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

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

It started in 2016-02-05 with completion listed for 2017-01-11.

It ran at 9 sites in Germany (5), United Kingdom (3) and Switzerland (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo.

It also tracked 3 secondary outcomes, for example Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo and Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 26 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 Relaxin (Serelaxin) compound page, all human trials.