VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
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)...
Brief Summary
Official Title: “A 26-week Double-blind, Randomized, Multicenter Parallel-group Trial to Compare the Effects of Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women With Impaired Exercise Tolerance”
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: valsartan
- Drug: atenolol
- Drug: hydrochlorothiazide
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171132
Study ID Number: CVAL489ADE21
ClinicalTrials.gov Identifier: NCT00171132
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171132
