Status:
COMPLETED
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
Lead Sponsor:
Novartis
Conditions:
Hypertension
Congestive Heart Failure
Eligibility:
All Genders
25-85 years
Phase:
PHASE4
Brief Summary
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
Eligibility Criteria
Inclusion
- 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
- • Present use of ACE inhibitor
- Other protocol-defined exclusion criteria may apply.
- \-
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00241098
Start Date
May 1 2003
End Date
June 1 2005
Last Update
October 18 2023
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