Congestive Heart Failure, Hypertension
Conditions
Keywords
HYPERTENSION, HEART FAILURE, PEPTIDE, valsartan
Brief summary
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
Interventions
DRUGvalsartan
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in a blood measurement for heart failure after 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed