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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171106

Enrollment

150

Registered

2005-09-15

Start date

2002-12-31

Completion date

2008-02-29

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Symptomatic Heart Failure

Keywords

diastolic dysfunction, heart failure, exercise tolerance, valsartan

Brief summary

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

Interventions

DRUGvalsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in baseline exercise test after 15-42 days and 14 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026