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-FI
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-03
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3183

Inclusion Criteria

- Male or female = 18 years of age with body weight = 40 Kg and = 160 Kg
- Systolic blood pressure =125 mmHg at the beginning 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the time to in-hospital Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death;Secondary Objective: - Evaluate the time to in-hospital WHF requiring rescue therapy/all cause death/readmission for HF.<br>- Evaluate the percentage of patients with persistent signs or symptoms of HF/ non-improvement <br>- Evaluate the percentage of patients with renal deterioration. <br>- Evaluate the length of stay. <br>;Primary end point(s): - Time to in-hospital Worsening of heart failure (WHF) requiring rescue therapy or all cause death through Day 5 post randomization.<br>- Time will be computed in hours from randomization to the earlier of the events. <br>;Timepoint(s) of evaluation of this end point: Trough Day 5 post randomization