- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02193243
Value of 6-minute Walk Test in Grown Ups With Congenital Heart Defects (GUCH)
December 14, 2014 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
The Diagnostic Value of Six-Minute Walk Test in Grown-Up Patients With Congenital Heart Disease (GUCH)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Duesseldorf, Germany, 40225
- Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patient with Congenital Heart Disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ranges of six-minute walk distance (6MWD)
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eva S Kehmeier, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
July 15, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 17, 2014
Study Record Updates
Last Update Posted (Estimate)
December 16, 2014
Last Update Submitted That Met QC Criteria
December 14, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Six-Minute Walk Test
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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