None listed
Conditions
Interventions
Group 1 Type of group
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
Group name:Group 3 Type of group
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Outpatients> 18 years of age, male or female. • Patients diagnosed with chronic heart failure (NYHA Class 11 - IV): LVEF 150 pg / mL (according to local measurement), or BNP> 100 pg / mL (according to local measurement) and unplanned hospitalization for 10 within the last 12 months prior to the visit 1. • Patients should be treated with an EGA inhibitor at a stable dose (enalapril at least 10 mg daily or any other EGA inhibitor, eg, ramipril, quinapril, lisinopril, fosinopril, perindopril, trandoiapril; based on equivalent doses as described in the guideline of dose equivalences of ACEIs) for at least 4 weeks before the visit 1. • Patients should be treated with a beta blocker unless it is contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not in the target dose, according to the local guides, or in the absence of that medication, the reason must be documented).
Exclusion criteria
Exclusion criteria: • History of hypersensitivity to any of the study drugs including history of allergy to ACE inhibitors, as well as known or suspected contraindications to study drugs or previous history of intolerance to high doses of ACEI during the ascending titration process. • Patients treated concomitantly with both BRA and aldosterone antagonists, in addition to the study drug at visit 1. • Acute IG, current decompensated. • Symptomatic hypotension and / or less than 95 mmHg of PSS at visit 1 and / or less than 90 mmHg at visit 4. • Kidney disease that is likely to be life-threatening or an eGFR <40 mL / mln / 1.73m2 measured by the MDRD formula at Visit 1 and an eGFR <35 mL / min / 1.73m2 measured by the MDRD formula at visit 4 or a eGFR decrease of more than 25% from visit 1 to visit 4 (according to a local laboratory measurement). • Serum potassium ^ 5.0 mmol / L at Visit 1 or 5.2 mmol / L at visit 4 (according to a local laboratory measurement). • Acute coronary syndrome, stroke, transient ischemia attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI), carotid angioplasty, within the last 3 months prior to the visit 1. • Coronary artery or carotid disease that probably requires surgical or percutaneous intervention within 6 months after the visit 1. • Right heart failure due to severe lung disease. • Diagnosis of peripartum or chemotherapy-induced cardiomyopathy in the last 12 months before the visit 1. • Patients with a history of heart transplantation or who are on a transplant list or with a DAVI device (left ventricular assist device). • Documented ventricular arrhythmia with syncopal episodes within the last 3 months without treatment, prior to the visit 1. • Symptomatic bradycardia or second or third degree heart block without pacemaker. • Implantation of a CRT device (cardiac resynchronization therapy) within the last 3 months prior to visit 1 or attempt to place a CRT device. • Presence of hemodynamically significant mitral and / or aortic vascular disease, except mitral regurgitation secondary to left ventricular dilation. • Presence of other hemodynamically significant obstructive lesions of the left ventricular outflow tract, including aortic stenosis. • Chronic long-term requirement of NSAIDs (high dose) or COX2 inhibitors with the exception of aspirin at the doses used for GV prophylaxis (<325 mg o.d.). • Current treatment with cyclosporine at visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF. Measure:Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization Timepoints:up to End of Study (78 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Measure:Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score Timepoints:Baseline, Month 12 ; Outcome name:Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event. Measure:All Causes of Death Timepoints:up to end of study (78 months) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea South, Latovia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom, United States, Venezuela
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed