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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Valsartan

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.

-