Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.

Phase 1

• Conditions: Acute heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002513-35-PT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-14
• Study Completion: 2017-04-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2650

Inclusion Criteria

- Male or female = 18 years of age with body weight = 40 Kg and = 160 Kg
- Systolic blood pressure =125 mmHg ate the beggining of the screening period (after ICF signature) and at the end of the screening period (prior to randomization)
- Admitted for AHF: Persistent dyspnea at rest or with minimal exertion, Pulmonary congestion assessed through physical examination and chest X-Ray
- Furosemide at any time between admission and the start of screening
- eGFR on admission: =25 and =75 mL/min/1.73 m2
- BNP =500 pg/mL or N-terminal pro b-type natriuretic peptide (NT-proBNP)=2,000 pg/mL

Other protocol-defined inclusion criteria may apply.
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 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2483

Exclusion Criteria

- Dyspnea (non-cardiac causes) such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, bronchitis, pneumonia), or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret the primary cause of dyspnea.
- T >38.5°C
- Clinical evidence of acute coronary syndrome
- AHF due to arrhythmias, acute myocarditis or cardiomyopathy
- Known history of respiratory disorders requiring the daily use of IV steroids (does not include inhaled or oral steroids) at least 2 months prior to randomization; need for intubation or the current use of IV steroids for COPD
- Patients with systolic blood pressure > 180 mmHg at end of screening or persistent heart rate >130 bpm
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year

Other protocol-defined exclusion criteria may apply.

Study & Design

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