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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171106
First received: September 10, 2005
Last updated: June 13, 2008
Last verified: June 2008
  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
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)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
valsartan

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

ClinicalTrials.gov processed this record on July 20, 2014