NCT02193243

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

July 15, 2014

Last Update Submit

December 14, 2014

Conditions

Congenital Heart Disease

Keywords

Congenital Heart DiseaseSix Minute Walk TestExercise TestingPeak oxygen uptake

Outcome Measures

Primary Outcomes (1)

  • Ranges of six-minute walk distance (6MWD)

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with Congenital Heart Disease

You may qualify if:

  • congenital heart defect
  • \> 18 years

You may not qualify if:

  • mental or physical incapability of exercise testing
  • non-cardiac limitations of physical capacity, as e.g. orthopedic diseases or febrile infections
  • severe psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • Kehmeier ES, Sommer MH, Galonska A, Zeus T, Verde P, Kelm M. Diagnostic value of the six-minute walk test (6MWT) in grown-up congenital heart disease (GUCH): Comparison with clinical status and functional exercise capacity. Int J Cardiol. 2016 Jan 15;203:90-7. doi: 10.1016/j.ijcard.2015.10.074. Epub 2015 Oct 22.

    PMID: 26498869DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Eva S Kehmeier, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Malte Kelm, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

June 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

DE(1)