Exercise Training in Grown-up Congenital Heart Disease (ExTra-GUCH)
|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.|
|ClinicalTrials.gov Identifier: NCT02825472|
Recruitment Status : Unknown
Verified July 2016 by Berto J Bouma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease.
Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.
Study design: International, multi-centre parallel randomized controlled trial.
Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III.
Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care.
Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Behavioral: exercise training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise Training in Grown-up Congenital Heart Disease|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Active Comparator: Exercise training program
Six-months sports participation, three times per week for 30 minutes in the target heart rate zone
Behavioral: exercise training
3 times per week 30 minutes of exercise training in the target heart rate zone
No Intervention: No exercise training program
no exercise training program, usual care
- Primary efficacy endpoint: change in peak VO2 [ Time Frame: 6 months ]change in peak VO2 between baseline and 6-months follow-up CPET
- Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise [ Time Frame: between 3 hours after exercise for the duration of the 6 months study period ]The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise.
- Secondary efficacy endpoint: quality of life [ Time Frame: 6 months ]change in SF36 scores between baseline and 6-months follow-up
- Secondary efficacy endpoint: NTproBNP level [ Time Frame: 6 months ]change in NTproBNP between baseline and 6-months follow-up
- Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought [ Time Frame: 6 months study period ]The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought during the study period
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): NCT02825472
|Contact: Berto Bouma, MD, PhDfirstname.lastname@example.org|
|Contact: Michiel Winter, MD, PhDemail@example.com|
|Department of Cardiology, I.R.C.C.S. Policlinico San Donato Milanese||Not yet recruiting|
|Milan, Piazza Edmondo Malan, Italy, 20097|
|Contact: Massimo Chessa, MD, PhD 0039252774531 firstname.lastname@example.org|
|Principal Investigator: Massimo Chessa, MD, PhD|
|Sub-Investigator: Roberto Tramarin, MD, PhD|
|Sub-Investigator: Francesca Pluchinotta, MD, PhD|
|Amsterdam, North-Holland, Netherlands, 1105AZ|
|Contact: Berto Bouma, MD, PhD 0031205669111 email@example.com|
|Contact: Michiel Winter, MD, PhD 0031205669111 firstname.lastname@example.org|
|Principal Investigator: Barbara Mulder, MD, PhD|
|Sub-Investigator: Michiel Winter, MD, PhD|
|Sub-Investigator: Ilja Blok, MD|
|Principal Investigator:||Barbara Mulder, MD, PhD||AIDS Malignancy Consortium|