Study of the Vascular Effects of Serelaxin

What Was Tested

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

This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.

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

Placebo was administered by intravenous infusion for 48 hours.

The registry classes the interventions as drug and other.

More on the Plan

Double blind, randomized, parallel group, placebo controlled study.

Who Took Part

58 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 and female patients ≥18 years of age, with body weight \<160 kg.

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: previous treatment with serelaxin (also known as: rlx030, relaxin); current or planned dialysis; current or history of pulmonary edema, including suspected sepsis.

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.

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

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

It started in 2014-02-03 with completion listed for 2016-08-17.

It ran at 3 sites in United Kingdom (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points (time frame: baseline to Day 3).

It also tracked 8 secondary outcomes, for example Change From Baseline in Aortic Distensibility Measured by MRI, Change From Baseline in Aortic Velocity, Change From Baseline in Augmentation Index Measured From Sphygmocor Device, Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance, Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis and Serum Concentration of Serelaxin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 58 people.

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

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