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

NCT ID: NCT00171106

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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Conditions

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Diastolic Dysfunction, Symptomatic Heart Failure

Keywords

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diastolic dysfunction heart failure exercise tolerance valsartan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Centers, , Germany

Site Status

Novartis Pharmaceuticals

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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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.

Reference Type RESULT
PMID: 19789402 (View on PubMed)

Other Identifiers

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CVAL489B2401

Identifier Type: -

Identifier Source: org_study_id