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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02193243
First Posted: July 17, 2014
Last Update Posted: December 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
  Purpose
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.

Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diagnostic Value of Six-Minute Walk Test in Grown-Up Patients With Congenital Heart Disease (GUCH)

Resource links provided by NLM:


Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Ranges of six-minute walk distance (6MWD) [ Time Frame: Baseline ]

Estimated Enrollment: 100
Study Start Date: June 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with Congenital Heart Disease
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193243


Locations
Germany
Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Eva S Kehmeier, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02193243     History of Changes
Other Study ID Numbers: Six-Minute Walk Test
First Submitted: July 15, 2014
First Posted: July 17, 2014
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
Congenital Heart Disease
Six Minute Walk Test
Exercise Testing
Peak oxygen uptake

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities