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Atrial Septal Defect - Exercise Capacity and Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03565471
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The purpose of the study is to compare exercise capacity, cardiac contractility, pulmonary vascular pressures and heart rate variability between patients with an atrial septal defect and healthy controls.

Condition or disease Intervention/treatment
Atrial Septal Defect Pulmonary Hypertension Diagnostic Test: Echocardiography Diagnostic Test: Right side catheterization Diagnostic Test: Exercise test Diagnostic Test: Holter monitor

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Atrial Septal Defect - Exercise Capacity and Pulmonary Hypertension
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ASD patients with surgical closure

Patients diagnosed with an ASD who have had a surgical closure of the defect more than 3 years ago.

Echocardiography, right side catheterization, exercise testing and Holter monitoring are performed on all participants.

Diagnostic Test: Echocardiography
Standard echocardiography.

Diagnostic Test: Right side catheterization
Right side catheterization with the purpose of measuring pulmonary vascular pressures and blood saturation.

Diagnostic Test: Exercise test
Exercise test on a supine bicycle with gradual increase in work load while wearing a mask that measures ventilation, oxygen uptake, carbon dioxide release and respiratory exchange rate.

Diagnostic Test: Holter monitor
Holter monitor worn for 2 whole days registering heart rate.

ASD patients with transcatheter closure

Patients diagnosed with an ASD who have had a transcatheter closure of the defect more than 3 years ago.

Echocardiography, right side catheterization, exercise testing and Holter monitoring are performed on all participants.

Diagnostic Test: Echocardiography
Standard echocardiography.

Diagnostic Test: Right side catheterization
Right side catheterization with the purpose of measuring pulmonary vascular pressures and blood saturation.

Diagnostic Test: Exercise test
Exercise test on a supine bicycle with gradual increase in work load while wearing a mask that measures ventilation, oxygen uptake, carbon dioxide release and respiratory exchange rate.

Diagnostic Test: Holter monitor
Holter monitor worn for 2 whole days registering heart rate.

Controls

Controls who do not have any cardiac or pulmonary diagnoses nor use prescription drugs that may affect the cardiopulmonary function.

Echocardiography, right side catheterization, exercise testing and Holter monitoring are performed on all participants.

Diagnostic Test: Echocardiography
Standard echocardiography.

Diagnostic Test: Right side catheterization
Right side catheterization with the purpose of measuring pulmonary vascular pressures and blood saturation.

Diagnostic Test: Exercise test
Exercise test on a supine bicycle with gradual increase in work load while wearing a mask that measures ventilation, oxygen uptake, carbon dioxide release and respiratory exchange rate.

Diagnostic Test: Holter monitor
Holter monitor worn for 2 whole days registering heart rate.




Primary Outcome Measures :
  1. Peak oxygen uptake (ml O2/kg/min) [ Time Frame: 8-12 minutes ]
    using exercise testing

  2. Peak exercise minute ventilation (ml/min) [ Time Frame: 8-12 minutes ]
    using exercise testing

  3. Peak heart rate (beats/min) [ Time Frame: 8-12 minutes ]
    using exercise testing

  4. Maximal workload (W/kg) [ Time Frame: 8-12 minutes ]
    using exercise testing


Secondary Outcome Measures :
  1. Tricuspid annular peak systolic velocity (mm) [ Time Frame: 8-12 minutes ]
    using echocardiography

  2. Return gradient at the tricuspid valve (mmHg) [ Time Frame: 8-12 minutes ]
    using echocardiography

  3. Cardiac output (L/min) [ Time Frame: 8-12 minutes ]
    using right sided catheterization

  4. Cardiac index (L/min) [ Time Frame: 8-12 minutes ]
    using right sided catheterization, derived measure adjusted for body surface area

  5. Central venous pressure (mmHg) [ Time Frame: 8-12 minutes ]
    using right sided catheterization

  6. Pulmonary artery wedge pressure (mmHg) [ Time Frame: 8-12 minutes ]
    using right sided catheterization

  7. Pulmonary artery pressure (mmHg) [ Time Frame: 8-12 minutes ]
    using right sided catheterization

  8. Mixed venous oxygen saturation (%) [ Time Frame: 8-12 minutes ]
    using right sided catheterization

  9. Heart rate variability [ Time Frame: 48 hours ]
    using Holter monitoring

  10. Heart rate, minimum, maximum and mean (beats/min) [ Time Frame: 48 hours ]
    using Holter monitoring


Biospecimen Retention:   Samples With DNA
2 mL blood sample


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The ASD patients will be identified through the Danish National Patient Registry (DNPR) and enrolled. The controls will be identified from the general population.
Criteria

Inclusion Criteria:

  • 18 years and above.
  • Informed consent to participate.
  • Patients: Diagnosed with an atrial septal defect. More than 3 years have passed since closure of the atrial septal defect.
  • Controls: No history of heart or lung disease.

Exclusion Criteria:

  • Lung disease.
  • Ischemic heart disease.
  • Diabetes.
  • Hypertension.
  • Valve pathology.
  • Patients: Concomitant heart disease
  • Controls: Usage of prescription drugs interfering with the cardiopulmonary function.

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): NCT03565471


Contacts
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Contact: Zarmiga Karunanithi, MD 004578453080 zarmkaru@rm.dk

Locations
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Denmark
Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Zarmiga Karunanithi, MD         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03565471     History of Changes
Other Study ID Numbers: 2018-21
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Atrial Septal Defect
Exercise Capacity
Pulmonary Hypertension
Heart Rate Variability
Congenital Heart Disease
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Heart Septal Defects
Heart Septal Defects, Atrial
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities