Back to resultsThe VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
Primary Purpose
Hypertension, Congestive Heart Failure
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring HYPERTENSION, HEART FAILURE, PEPTIDE, valsartan
Eligibility Criteria
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. -
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline in a blood measurement for heart failure after 26 weeks
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241098
Brief Title
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Congestive Heart Failure
Keywords
HYPERTENSION, HEART FAILURE, PEPTIDE, valsartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan
Primary Outcome Measure Information:
Title
Change from baseline in a blood measurement for heart failure after 26 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in a blood measurement for heart failure after 12 weeks
Title
Change in baseline heart size after 26 weeks
Title
Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks
Title
Change from baseline in markers of heart fibrosis after 26 weeks
Title
Change from baseline quality of life questionnaire after 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceutical
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
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