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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: hydrochlorothiazide; Drug: valsartan; Drug: atenolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171132

CVAL489ADE21

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind