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

• Status: Terminated
• Trial end date: 2017-01-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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.