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This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in a blood measurement for heart failure after 26 weeks |
| Measure | Description | 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 |
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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
Exclusion Criteria:
• Present use of ACE inhibitor
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceutical | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Change from baseline in markers of heart fibrosis after 26 weeks |
| Change from baseline quality of life questionnaire after 26 weeks |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |