The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure

Condition(s) targeted: Hypertension; Congestive Heart Failure

Intervention: valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceutical, Study Director, Affiliation: Novartis

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

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: Change from baseline in a blood measurement for heart failure after 26 weeks

Secondary outcome:

Change from baseline in a blood measurement for heart failure after 12 weeks

Change in baseline heart size after 26 weeks

Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks

Change from baseline in markers of heart fibrosis after 26 weeks

Change from baseline quality of life questionnaire after 26 weeks

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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Last updated: June 1, 2006