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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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