Study of the effect of serelaxin on high-sensitivity cardiac troponin I (hs cTnI) release in patients with chronic heart failure

Phase 1

• Conditions: Chronic Heart Failure; MedDRA version: 19.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002673-38-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1. Provide written informed consent before any assessment is performed.
2. Male or female = 18 years of age, with body weight = 160 Kg.
3. Diagnosis of stable CHF:
- New York Heart Association (NYHA) functional Class II/III.
- Receiving guideline-recommended treatment for CHF.
4. Left ventricular ejection fraction < 50%, obtained within the last 3 months prior to screening.
5. NT-proBNP > 250 ng/L in sinus rhythm or > 750 ng/L if not in sinus rhythm (determined locally).
6. Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
7. Systolic BP = 125 mm Hg at screening.
8. Renal function defined as an eGFR of = 25 mL/min/1.73 m2 at screening (sMDRD formula).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Dyspnea primarily due to non-cardiac causes.
2. Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
3. Any contraindication for exercise testing and spirometry.
4. 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.
5. Change in guideline-recommended CHF treatment within 1 month prior to screening.
6. Clinical evidence of acute coronary syndrome within 90 days prior to enrollment.
7. Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate < 45 beats per minute or atrial fibrillation/flutter with sustained ventricular response of > 90 beats per minute at rest.
8.Severe renal impairment defined as eGFR < 25 mL/min/1.73m2 before randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified