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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241098
• Other study ID #: CVAL489B2402
• Status: Completed
• Phase: Phase 4
• Start date: May 2003
• Est. completion date: June 2005

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Hypertension

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in a blood measurement for heart failure after 26 weeks
Secondary	Change from baseline in a blood measurement for heart failure after 12 weeks
Secondary	Change in baseline heart size after 26 weeks
Secondary	Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks
Secondary	Change from baseline in markers of heart fibrosis after 26 weeks
Secondary	Change from baseline quality of life questionnaire after 26 weeks