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The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | |||
| atenolol | Drug | |||
| hydrochlorothiazide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography | ||
| Change from baseline in heart rate and blood pressure, | ||
| during exercise testing after 26 weeks |
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Inclusion Criteria:
VO2max >14 and < 22 ml â‹…kg-1 â‹…min-1
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Centers | Germany | |||||
| Novartis Pharmaceuticals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19300114 | Result | Dusing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894-901. doi: 10.1097/HJH.0b013e328323f9be. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D001262 | Atenolol |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Change from baseline in heart size after 26 weeks, measured by echocardiography |
| Change from baseline in quality of life measures after 26 weeks |
| Basel |
| Switzerland |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |