Hypertension
Conditions
Keywords
Postmenopausal, women, overweight, hypertension, impaired, exercise, capacity, valsartan, atenolol, hydrochlorothiazide
Brief summary
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).
Interventions
DRUGvalsartan
DRUGatenolol
DRUGhydrochlorothiazide
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Body mass index (BMI) must be ≥ 27 and \< 35 * Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy * LV ejection fraction must be \> 45% measured by echocardiography at Visit 2. * Impaired exercise capacity measured by VO2max at Visit 4: VO2max \>14 and \< 22 ml ⋅kg-1 ⋅min-1
Exclusion criteria
* Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg * LVEF ≤ 45 % * Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study * Heavy smokers (\>20 cigarettes/day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks | — |
Secondary
| Measure | 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 | — |
| Change from baseline in heart size after 26 weeks, measured by echocardiography | — |
| Change from baseline in quality of life measures after 26 weeks | — |
Countries
Germany, Switzerland
Outcome results
None listed