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

Novartis0 sites37 target enrollmentMay 2003

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 37
Primary Endpoint: Change from baseline in a blood measurement for heart failure after 26 weeks
Status: Completed
Last Updated: 2 years ago

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

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

June 2005

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

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

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