Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diastolic Dysfunction, Symptomatic Heart Failure
Intervention: valsartan (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
This study will test the effects of valsartan versus placebo on exercise tolerance in
patients with symptoms of heart failure
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in baseline exercise test after 15-42 days and 14 weeks
Secondary outcome: Oxygen consumption during the exercise testExercise 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
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Investigative Centers, Germany
Novartis Pharmaceuticals, Basel, Switzerland
Additional Information
Starting date: December 2002
Last updated: March 9, 2007
|
