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Trial record 7 of 16930 for:    "Heart Diseases"

Exercise Training in Grown-up Congenital Heart Disease (ExTra-GUCH)

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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
Sponsor:
Information provided by (Responsible Party):
Berto J Bouma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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

Detailed Description:
The investigators intend to submit the trial design of this study for this purpose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Outcome Measures :
  1. Primary efficacy endpoint: change in peak VO2 [ Time Frame: 6 months ]
    change in peak VO2 between baseline and 6-months follow-up CPET

  2. 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 Outcome Measures :
  1. Secondary efficacy endpoint: quality of life [ Time Frame: 6 months ]
    change in SF36 scores between baseline and 6-months follow-up

  2. Secondary efficacy endpoint: NTproBNP level [ Time Frame: 6 months ]
    change in NTproBNP between baseline and 6-months follow-up

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Congenital heart disease of all complexities
  • NYHA Class II or III

Exclusion Criteria:

  • Inability to give informed consent
  • Inability to participate in an exercise training program
  • Exercise-induced arrhythmia and/or ischemia
  • Cyanosis at rest
  • Pregnancy
  • Major cardiovascular event and/or procedure within three months previous to inclusion.
  • Participation in interventional clinical trial

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): NCT02825472


Contacts
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Contact: Berto Bouma, MD, PhD 0031205669111 b.j.bouma@amc.uva.nl
Contact: Michiel Winter, MD, PhD 0031205669111 m.m.winter@amc.uva.nl

Locations
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Italy
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    massimo.chessa@grupposandonato.it   
Principal Investigator: Massimo Chessa, MD, PhD         
Sub-Investigator: Roberto Tramarin, MD, PhD         
Sub-Investigator: Francesca Pluchinotta, MD, PhD         
Netherlands
Hospital Recruiting
Amsterdam, North-Holland, Netherlands, 1105AZ
Contact: Berto Bouma, MD, PhD    0031205669111    b.j.bouma@amc.uva.nl   
Contact: Michiel Winter, MD, PhD    0031205669111    m.m.winter@amc.uva.nl   
Principal Investigator: Barbara Mulder, MD, PhD         
Sub-Investigator: Michiel Winter, MD, PhD         
Sub-Investigator: Ilja Blok, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Barbara Mulder, MD, PhD AIDS Malignancy Consortium

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Responsible Party: Berto J Bouma, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02825472     History of Changes
Other Study ID Numbers: NL5378201815
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Berto J Bouma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Congenital Heart Disease
Sport
Exercise training

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