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

Primary Purpose

Diastolic Dysfunction, Symptomatic Heart Failure

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

valsartan

About this trial

This is an interventional treatment trial for Diastolic Dysfunction, Symptomatic Heart Failure focused on measuring diastolic dysfunction, heart failure, exercise tolerance, valsartan

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00171106

First Posted

September 10, 2005

Last Updated

November 16, 2016

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00171106

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diastolic Dysfunction, Symptomatic Heart Failure

Keywords

diastolic dysfunction, heart failure, exercise tolerance, valsartan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

valsartan

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Oxygen consumption during the exercise test

Title

Exercise test blood pressure

Title

Borg score of breathlessness

Title

6-minute walk test at baseline and after 14 weeks

Title

Quality of life assessment at baseline and after 14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Investigative Centers

Country

Germany

Facility Name

Novartis Pharmaceuticals

City

Basel

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

19789402

Citation

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.

Results Reference

result

Learn more about this trial

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

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