Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
Phase 4
Completed
- Conditions
- Diastolic Dysfunction, Symptomatic Heart Failure
- Registration Number
- NCT00171106
- Lead Sponsor
- Novartis
- Brief Summary
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in baseline exercise test after 15-42 days and 14 weeks
- Secondary Outcome Measures
Name Time Method Borg score of breathlessness 6-minute walk test at baseline and after 14 weeks Oxygen consumption during the exercise test Quality of life assessment at baseline and after 14 weeks Exercise test blood pressure
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨🇭Basel, Switzerland
Novartis Pharmaceuticals🇨🇭Basel, Switzerland