Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure

Diastolic Dysfunction, Symptomatic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171106
• Other study ID #: CVAL489B2401
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: November 16, 2016
• Start date: December 2002
• Est. completion date: February 2008

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2008
• Est. primary completion date: August 2007
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Dysfunction, Symptomatic Heart Failure
• Heart Failure

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

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 preserve — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline exercise test after 15-42 days and 14 weeks
Secondary	Oxygen consumption during the exercise test
Secondary	Exercise test blood pressure
Secondary	Borg score of breathlessness
Secondary	6-minute walk test at baseline and after 14 weeks
Secondary	Quality of life assessment at baseline and after 14 weeks

External Links

•   Results for CVAL489B2401 from the Novartis Clinical Trials website