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

Chronic Heart Failure Clinical Trial

— RELAX-Cardio  

Official title:

A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02625922
• Other study ID #: CRLX030A2211
• Secondary ID: 2015-002673-38
• Status: Terminated
• Phase: Phase 2
• Start date: February 5, 2016
• Est. completion date: January 11, 2017

Study information

• Verified date: January 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 11, 2017
• Est. primary completion date: January 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Serelaxin
Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
• Placebo
Matching placebo i.v infusion

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Greifswald	Mecklenburg Vorpommern
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Switzerland	Novartis Investigative Site	Basel
United Kingdom	Novartis Investigative Site	Hull
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo	This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.	Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)
Secondary	Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours	This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.	4 and 5 hours after exercise testing session
Secondary	Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo	This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.	Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
Secondary	Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo	This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.	Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)