VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00171132
• Lead Sponsor: Novartis

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland