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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension; Congestive Heart Failure

Treatments: Drug: valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00241098

CVAL489B2402

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind