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OpenTrials
Completed

NCT Number: NCT00171106

Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure

This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure

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Key information

Conditions

Diastolic Dysfunction, Symptomatic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Symptomatic diastolic heart failure
  • Breathlessness with physical exertion

Exclusion criteria

  • Uncontrolled hypertension
  • Asthma, COPD, or abnormal lung function
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Allergy to valsartan

Other protocol-defined exclusion criteria may apply

Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change in baseline exercise test after 15-42 days and 14 weeks

Secondary outcomes

  1. Oxygen consumption during the exercise test

  2. Exercise test blood pressure

  3. Borg score of breathlessness

  4. 6-minute walk test at baseline and after 14 weeks

  5. Quality of life assessment at baseline and after 14 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Nov 18, 2016

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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