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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 10, 2005
Last updated: June 13, 2008
Last verified: June 2008
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure

Condition Intervention Phase
Diastolic Dysfunction, Symptomatic Heart Failure
Drug: valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in baseline exercise test after 15-42 days and 14 weeks

Secondary Outcome Measures:
  • Oxygen consumption during the exercise test
  • Exercise test blood pressure
  • Borg score of breathlessness
  • 6-minute walk test at baseline and after 14 weeks
  • Quality of life assessment at baseline and after 14 weeks

Estimated Enrollment: 150
Study Start Date: December 2002
Study Completion Date: February 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00171106

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00171106     History of Changes
Other Study ID Numbers: CVAL489B2401 
Study First Received: September 10, 2005
Last Updated: June 13, 2008
Health Authority: United Kingdom: National Health Service

Keywords provided by Novartis:
diastolic dysfunction
heart failure
exercise tolerance

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016