DRUG
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
Status
Completed
Phase
Phase 4
Enrollment
37
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 18, 2005
Study start
May 2003
Primary completion
Jun 2005
Study completion
Jun 2005
Results posted
Not reported
Registry updated
Oct 18, 2023
Outcomes
What the study measures.
Primary outcomes
Change from baseline in a blood measurement for heart failure after 26 weeks
Secondary outcomes
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
Eligibility
Who can take part.
- Minimum age
- 25 Years
- Maximum age
- 85 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.