A Randomized, Double Blind, Parallel Group Study to Evaluate the Effects of Valsartan Versus Placebo in Patients With Early Stage Heart Failure Due to Diastolic Dysfunction Already Evidenced by an Elevated B-type Natriuretic Peptide Level: the VALIDATE Study

CVAL489B2402

This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.

2003-05-01

2005-06-01

2005-06-01

Completed

Early phase I

37

Inclusion Criteria: * Male or female 25-85 years of age, inclusive * Past diagnosis of hypertension for a min 1 year * Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months * BP is considered adequately controlled with DBP \< 90mmHg * Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory * LV ejection fraction ³ 45% * LVH defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females * At least one of the following parameters of diastolic dysfunction * E/A \< 1 for the patients who are younger than 55 years or \< 0.8 for the patients whose age is ³ 55 years (full year), or * DT \> 220 ms, or * IVRT \> 90 ms Exclusion Criteria: • Present use of ACE inhibitor Other protocol-defined exclusion criteria may apply. -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-10-18