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

This study has been completed.

First Received on September 10, 2005. Last Updated on June 13, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171106

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 IV

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:

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

Drug Information available for: Valsartan

U.S. FDA Resources

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

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

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 February 09, 2012