NCT00171106CompletedPhase 4
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Change in baseline exercise test after 15-42 days and 14 weeks
Study Overview
Brief Summary
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in baseline exercise test after 15-42 days and 14 weeks
Secondary Outcomes
- Borg score of breathlessness
- Quality of life assessment at baseline and after 14 weeks
- Exercise test blood pressure
- 6-minute walk test at baseline and after 14 weeks
- Oxygen consumption during the exercise test
Investigators
Study Sites (2)
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