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

Novartis150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Diastolic Dysfunction, Symptomatic Heart Failure

Interventions

valsartanDRUG

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change in baseline exercise test after 15-42 days and 14 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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