Efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure

Phase 1

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

• Registration Number: EUCTR2013-001498-25-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-24
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6800

Inclusion Criteria

-Male or female 18 years of age, with body weight =160 kg
-Hospitalized for AHF with the anticipated requirement of intravenous therapy (including IV diuretics) for at least 48 hours, i.e. persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization, despite standard background therapy for acute heart failure including the protocol required intravenous furosemide of at least 40 mg total (or equivalent), pulmonary congestion on chest radiograph, BNP =500 pg/mL or NT-proBNP =2,000 pg/mL; for patients = 75 years of age or with current atrial fibrillation (at the time of randomization), BNP = 750 pg/mL or NT-proBNP = 3,000 pg/mL
-Systolic BP =125 mmHg at the start and at the end of screening
-Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
-Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode. Time from presentation to start of furosemide administration must be less than 6 hours.
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 1565
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5235

Exclusion Criteria

-Dyspnea due to non-cardiac causes such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, bronchitis, pneumonia), which may interfere with the ability to interpret the primary cause of dyspnea
-Known history of respiratory disorders requiring the daily use of IV or oral steroids (does not include inhaled steroids); need for intubation or the current use of IV or oral steroids for COPD
- Patients with blood pressure > 180 mmHg at the time of randomization or persistent heart rate >130 bpm
-Temperature>38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
-Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
-AHF due to 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 >130 beats per minute
-Patients with severe renal impairment defined as pre-randomization eGFR < 25mL/min/1.73m2 calculated using the sMDRD equation, and/or those receiving current or planned dialysis or ultrafiltration Other protocol defined inclusion/exclusion criteria may apply.

Study & Design

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