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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT02193243
First received: July 15, 2014
Last updated: July 28, 2014
Last verified: July 2014
  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 Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Ranges of six-minute walk distance (6MWD) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02193243

Contacts
Contact: Eva S Kehmeier, MD 00492118118800
Contact: Rabea Wagstaff, M.A. 00492118118800 rabea.wagstaff@med.uni-duesseldorf.de

Locations
Germany
Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine Recruiting
Duesseldorf, Germany, 40225
Contact: Eva Sq Kehmeier, MD    00492118118800      
Principal Investigator: Eva S Kehmeier, MD         
Sub-Investigator: Margot H Petersen, MD         
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

No publications provided

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
Study First Received: July 15, 2014
Last Updated: July 28, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014