Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients

What Was Tested

This registered phase 2 trial tested Relaxin (Serelaxin).

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.

The registry classes the interventions as drug.

Who Took Part

The registry lists 46 actual participants took part.

It was open to people of any sex aged from 20 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 study-specific assessment is performed. Male or female ≥20 years of age, with body weight ≥30 kg and ≤160 kg. Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:. Dyspnea at rest or with minimal exertion. Pulmonary congestion on chest radiograph.

The full record lists 10 inclusion and 4 exclusion criteria; among the exclusions: dyspnea primarily due to non-cardiac causes; temperature \>38.5°c (oral or equivalent) or sepsis or active infection requiring iv anti-microbial treatment; clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

The Relaxin (Serelaxin) group and the comparison group ran side by side rather than switching.

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 2014-01 with completion listed for 2014-08.

It ran at 15 sites in Japan (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum Plasma Concentration (Cmax) of Serelaxin. Weight Adjusted Clearance (CL) of Serelaxin. Concentration at Steady-state (Css) of Serelaxin.

It also tracked 6 secondary outcomes, for example Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5, Change From Baseline in Aldosterone Levels Through Day 14, Change From Baseline in Cystatin-C Levels Through Day 14, Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14, Change From Baseline in NT-proBNP Levels Through Day 14 and Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Relaxin (Serelaxin) in 46 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.