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

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug); atenolol (Drug); hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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).

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

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

Primary outcome: Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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)

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: August 2004
Last updated: July 6, 2007