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Completed

NCT Number: NCT00171132

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).

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Key information

Conditions

Hypertension Behavior Body Weight Cardiovascular Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Centers, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

valsartan

Drug

Atenolol

Drug

Hydrochlorothiazide

Drug

Primary outcomes

  1. Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks

Secondary outcomes

  1. Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography

  2. Change from baseline in heart rate and blood pressure,

  3. during exercise testing after 26 weeks

  4. Change from baseline in heart size after 26 weeks, measured by echocardiography

  5. Change from baseline in quality of life measures after 26 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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