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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171106
First Posted: September 15, 2005
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171106


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00171106     History of Changes
Other Study ID Numbers: CVAL489B2401
First Submitted: September 10, 2005
First Posted: September 15, 2005
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
diastolic dysfunction
heart failure
exercise tolerance
valsartan

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