A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the 6 months efficacy and safety of aliskiren therapy on top of standard therapy, on morbidity and mortality when initiated early after hospitalization for acute decompensated heart failure - ND

• Conditions: heart failure; MedDRA version: 9.1Level: LLTClassification code 10011949Term: Decompensation cardiac

• Registration Number: EUCTR2009-010236-18-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-14
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1782

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Patient hospitalized with a primary diagnosis of worsening heart failure &#8805; 18 years of age, male or female. 2. Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e. jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization. LVEF < 40% (measured within the last 6 months). Hospitalization for ADHF and remain ?stabilized? for at least 6 hours (defined as SBP &#8805; 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization. 3. Elevated BNP at Visit 1 (BNP &#8805; 400 pg/ml) (measured locally) 4. Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization. (NYHA Class II ? IV) 5. Written informed consent to participate in the study. 6. Ability to comply with all study requirements
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

Exclusion Criteria

1. Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization 2. Concomitant use of ACEI and ARB at randomization 3. Right heart failure due to pulmonary disease 4. Diagnosis of postpartum cardiomyopathy 5. Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months. 6. Patients with a history of heart transplant or who are on a transplant list 7. Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) before randomization. 8. Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated 9. Presence of hemodynamically significant mitral stenosis or mitral regurgitation, except mitral regurgitation secondary to left ventricular dilatation 10. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis 11. Persistent systolic blood pressure < 110 mm Hg 12. Stroke within the past 3 months 13. Primary liver disease considered to be life threatening 14. Serum potassium > 5.0 mEq/L (5.0 mmol/L) at Visit 2 (measured locally) 15. Severe hyponatremia < 130 meq/l at Visit 2 (measured locally) 16. Renal disease or eGFR < 40 ml/min/1.73m2 (as measured by the MDRD formula) at Visit 2 (measured locally) 17. History or presence of any other diseases (i.e. including malignancies) with a life expectancy of < 3 years 18. Prior (defined as less then 30 days from randomization) or current double-blind treatment in CHF trials or participation in an investigational drug study within the past 30 days 19. History of hypersensitivity to any of the study medications or to medications belonging to the same therapeutic class as the study medications 20. Any condition that in the opinion of the investigator or medical monitor would jeopardize the evaluation of efficacy or safety 21. History of noncompliance to medical regimens and patients who are considered potentially unreliable 22. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test (> 5 mIU/ml) 23. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, and oral), and double-barrier methods (if accepted by local regulatory authority and ethics committee). Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation 24. Treatment with any of the following drugs within the past 3 months prior to Visit

Study & Design

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