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NCT02193243 Clinical Trial

Value of 6-minute Walk Test in Grown Ups With Congenital Heart Defects (GUCH)

Congenital Heart Disease Clinical Trial

Official title:
The Diagnostic Value of Six-Minute Walk Test in Grown-Up Patients With Congenital Heart Disease (GUCH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02193243
Other study ID # Six-Minute Walk Test
Secondary ID
Status Completed
Phase N/A
First received July 15, 2014
Last updated December 14, 2014
Start date June 2013
Est. completion date August 2014

Study information
Verified date December 2014
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The six-minute walk test is an established submaximal exercise test. Its role in examination of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of this study was a comparison of the 6MWT with other established parameters of functional capacity, in grown-up patients with GUCH.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- congenital heart defect

- > 18 years

Exclusion Criteria:

- mental or physical incapability of exercise testing

- non-cardiac limitations of physical capacity, as e.g. orthopedic diseases or febrile infections

- severe psychiatric diseases

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine Duesseldorf

Sponsors (1)
Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ranges of six-minute walk distance (6MWD) Baseline No
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