Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.
- Conditions
- Acute heart failureTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-002513-35-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2650
- 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
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
- 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
Other protocol-defined exclusion criteria may apply.
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 <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: Through Day 5 post randomization;Main Objective: Evaluate the time to in-hosptial Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death.;<br> Secondary Objective: - Evaluate the time to in-hospital WHF requiring rescue therapy/all cause death/readmission.<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>
- Secondary Outcome Measures
Name Time Method