A MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO- CONTROLLED PHASE IIIB STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SERELAXIN WHEN ADDED TO STANDARD THERAPY IN ACUTE HEART FAILURE PATIENTS
- Conditions
- -I50I50
- Registration Number
- PER-023-15
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
1. Written informed consent must be obtained before any study specific assessment is performed.
2. Male or female≥ 18 years of age, with body weight ≤ 160 kg.
3. Hospitalized for AHF with the anticipated requierement of intravenous therapy (including IV diuretics) for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department) and the end of screening:
- 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- pro BNP ≥ 2000 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 ≥3000 pg/mL.
4. Systolic BP ≥ 125 mmHg at the start and at the end of screening.
5. Able to be randomized within 16 hours from presentation to the hospital, including the emergency department.
6. 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 fro the treatment of the current acute HF episode. Time from presentation to start of furosemide administration should be less than 6 hours.
1. 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.
2. Know history of respiratory disorders requiring the daily use of IV or oral steroids; need for intubation or the current use of IV or oral steroids for COPD.
3. Patients with blood pressure > 180 mmHg at the time of randomization or persistent heart rate >130 bpm.
4. Temperature > 38.5°C (oral or equivalent) or sepsis or active infection requiring IV antimicrobial treatment.
5. Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment ( Note that the diagnosis of acute coronary syndrome is a clinical diagnosis and that the sole presence of elevated troponin concentrations is not sufficient for a diagnosis of acute coronary syndrome, given that troponin cincentrations may be significantly increased in the setting of AHF.)
6. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method