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

Phase 4

Completed

• Conditions: Hypertension; Congestive Heart Failure

• Registration Number: NCT00241098
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in a blood measurement for heart failure after 26 weeks

Secondary Outcome Measures

Name	Time	Method
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