A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure - RELAX
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10007554Term: Cardiac failurepatients hospitalized with acute heart failure (AHF), hypertension and mild to moderate renal impairment
- Registration Number
- EUCTR2007-004271-19-IT
- Lead Sponsor
- BAS Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2330
1. Able to provide written informed consent 2. Male or female ≥ 18 years of age, with body weight <115 kg 3. Systolic blood pressure > 125 mmHg at the time of screening 4. Hospitalized for AHF. AHF is defined as including all of the following at screening: a. Dyspnea at rest or with minimal exertion b. Pulmonary congestion as evidenced by interstitial edema on chest radiograph c. BNP ≥ 350pg/mL or NT-pro-BNP ≥1400 pg/mL measured at any time between presentation (including the emergency department [ED]) and screening 5. Able to be randomized within 16 hours from presentation to the hospital, including the ED 6. Received IV furosemide of at least 40 mg (or equivalent) at any time between admission to emergency services (either ambulance or hospital, including the ED) and screening for the study 7. Impaired renal function defined as a creatinine clearance on admission between 30-75 mL/min, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant or breast-feeding women (women of child bearing potential must have theresults of a negative pregnancy test recorded prior to study drug administration) 2. Administration of intravenous radiographic contrast agent within 72 hours prior to screening or acute contrast-induced nephropathy at the time of screening 3. Temperature >38C (oral or equivalent) or sepsis or active infection requiring IV antimicrobial treatment 4. Current (within 2 hours prior to screening) or planned (through the completion of study drug infusion) treatment with any IV therapies, including vasodilators (including nesiritide), positive inotropic agents and vasopressors, or mechanical support (intraaortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device), with the exception of IV nitrates at a dose of < 0.1 mg/kg/hr if the patient has a systolic BP > 150 mmHg at screening 5. Current or planned ultrafiltration, hemofiltration, or dialysis 6. Diabetic nephropathy with proteinuria +2 or greater by dipstick 7. Significant pulmonary disease (history of oral daily steroid dependency, history of dependency on bronchodilators or need for intubation in the past for acute exacerbation,or currently receiving IV steroids) 8. Significant stenotic valvular disease (severe aortic stenosis [AVA < 1.0 or peak gradient > 50 on prior or current echocardiogram], or severe mitral regurgitation, severe aortic regurgitation, or severe mitral stenosis) 9. Any organ transplant recipient, or patient currently listed for transplant or admitted for any transplantation 10. Major surgery within 30 days 11. Hematocrit < 25% or blood transfusion in the prior 14 days or active, life-threatening GI bleeding 12. Major neurologic event, including cerebrovascular events, in the prior 60 days 13. Clinical diagnosis of acute coronary syndrome within 45 days prior to screening(including the present admission) as determined by both clinical and enzymatic criteria 14. Troponin > 3 times the upper limit of normal between presentation and screening. 15. AHF due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate <45 beats per minute or any second or third degree AV block or atrial fibrillation/flutter with ventricular response of >120 beats per minute) 16. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function) 17. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, albumin < 2.8 mg/dL, or increased ammonia levels if performed) 18. Non-cardiac pulmonary edema, including suspected sepsis 19. Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening or previous treatment with relaxin 20. Inability to follow instructions or comply with follow-up procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method