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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valsartan
• Drug: atenolol
• Drug: hydrochlorothiazide

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

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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis  

Information obtained from ClinicalTrials.gov on September 05, 2008

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