Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
Primary Purpose
Diastolic Dysfunction, Symptomatic Heart Failure
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Dysfunction, Symptomatic Heart Failure focused on measuring diastolic dysfunction, heart failure, exercise tolerance, valsartan
Eligibility 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
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171106
Brief Title
Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Dysfunction, Symptomatic Heart Failure
Keywords
diastolic dysfunction, heart failure, exercise tolerance, valsartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan
Primary Outcome Measure Information:
Title
Change in baseline exercise test after 15-42 days and 14 weeks
Secondary Outcome Measure Information:
Title
Oxygen consumption during the exercise test
Title
Exercise test blood pressure
Title
Borg score of breathlessness
Title
6-minute walk test at baseline and after 14 weeks
Title
Quality of life assessment at baseline and after 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Investigative Centers
Country
Germany
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19789402
Citation
Parthasarathy HK, Pieske B, Weisskopf M, Andrews CD, Brunel P, Struthers AD, MacDonald TM. A randomized, double-blind, placebo-controlled study to determine the effects of valsartan on exercise time in patients with symptomatic heart failure with preserved ejection fraction. Eur J Heart Fail. 2009 Oct;11(10):980-9. doi: 10.1093/eurjhf/hfp120.
Results Reference
result
Learn more about this trial
Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
We'll reach out to this number within 24 hrs