A twelve-week, randomized, double-blind, multi-center,parallel group, active controlled study to evaluate the efficacy, safety and tolerability of LCZ696 compared to valsartan in patients with chronic heart failure and preserved left-ventricular ejection fraction - ND

• Conditions: Chronic heart failure; MedDRA version: 9.1Level: LLTClassification code 10008908Term: Chronic heart failure

• Registration Number: EUCTR2009-010208-27-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-06
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Male or female outpatients, ≥ 40 years of age. Patients with documented stable chronic heart failure (NYHA II-IV): ? LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography); the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction. ? Plasma NT-proBNP > 500 pg/ml at Visit 1. ? Patients with documented stable chronic heart failure (NYHA II-IV). ? Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1. ? Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted). ? Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2). Patients with at least one of the following symptoms at the time of screening (Visit 1): ? Dyspnea on exertion ? Orthopnea ? Paroxysmal nocturnal dyspnea ? Peripheral edema Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula). Patients with a potassium ≤5.2 mmol/l at Visit 1.
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

Patients with a prior LVEF reading <45%, at ANY time. Patients who require treatment with both an ACE inhibitor and an ARB. Isolated right heart failure due to pulmonary disease. Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity Presence of hemodynamically significant mitral and /or aortic valvular diseases Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis and sub-aortic valvular stenosis Presence of hypertrophic obstructive cardiomyopathy Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloid disease) Patients with a history of any organ transplant or who are on a transplant list (life expectancy < 6 months at time of entry into the study) Patients with a mean sitting systolic blood pressure &#8804;100 mm Hg Coronary artery disease likely to require coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) during the course of the study. Patients with angina pectoris requiring pharmacological therapy are allowed entry into the study History of myocardial infarction, unstable angina, coronary bypass surgery or any PCI, stroke or TIA during the past 3 months prior to Visit 1. Clinically significant second or third degree heart block without a pacemaker. Atrial fibrillation with a resting heart rate >100 bpmPatients with an implantable cardioverter defibrillator (ICD) that has discharged in the past 1 month. Episode(s) of malignant ventricular tachycardia or any other types of severe arrhythmia producing significant hemodynamic consequences or considered life-threatening within 3 months of Visit 1. Patients with a known history of angioedema. Known or suspected contraindications, including history of allergy to ARBs, neutral endopeptidase inhibitor (NEPi)

Study & Design

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