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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-05

Study Completion Date

2017-01-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Serelaxin followed by Placebo

On Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.

Group Type EXPERIMENTAL

Serelaxin

Intervention Type DRUG

Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen

Placebo

Intervention Type DRUG

Matching placebo i.v infusion

Placebo followed by Serelaxin

On Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.

Group Type EXPERIMENTAL

Serelaxin

Intervention Type DRUG

Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen

Placebo

Intervention Type DRUG

Matching placebo i.v infusion

Interventions

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Serelaxin

Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen

Intervention Type DRUG

Placebo

Matching placebo i.v infusion

Intervention Type DRUG

Other Intervention Names

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RLX030

Eligibility Criteria

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Inclusion Criteria

* 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.
* Left ventricular ejection fraction \< 45%, obtained within the last 3 months prior to screening.
* NT-proBNP \> 300 ng/L in sinus rhythm or \> 900 ng/L if not in sinus rhythm (determined locally).
* Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
* Systolic BP ≥ 125 mmHg at randomization
* Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m\^2 at screening (sMDRD formula).

Exclusion Criteria

* Dyspnea primarily due to non-cardiac causes.
* Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
* Any contraindication for exercise testing and spirometry.
* Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) \> 1.05.
* Change in guideline-recommended CHF treatment within 1 month prior to screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No