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

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Primary Completion: 2007-08
• Study Completion: 2008-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

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
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland