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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Chronic Heart Failure

Treatments: Drug: Placebo; Drug: Serelaxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02625922

2015-002673-38 (EudraCT Number)

CRLX030A2211

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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).

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 2 patient groups

Serelaxin followed by Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Serelaxin

Placebo followed by Serelaxin

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Serelaxin