NCT03565471

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

June 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 6, 2021

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 18, 2018

Last Update Submit

May 4, 2021

Conditions

Atrial Septal DefectPulmonary Hypertension

Keywords

Atrial Septal DefectExercise CapacityPulmonary HypertensionHeart Rate VariabilityCongenital Heart Disease

Outcome Measures

Primary Outcomes (4)

  • Peak oxygen uptake (ml O2/kg/min)

    using exercise testing

    8-12 minutes

  • Peak exercise minute ventilation (ml/min)

    using exercise testing

    8-12 minutes

  • Peak heart rate (beats/min)

    using exercise testing

    8-12 minutes

  • Maximal workload (W/kg)

    using exercise testing

    8-12 minutes

Secondary Outcomes (10)

  • Tricuspid annular peak systolic velocity (mm)

    8-12 minutes

  • Return gradient at the tricuspid valve (mmHg)

    8-12 minutes

  • Cardiac output (L/min)

    8-12 minutes

  • Cardiac index (L/min)

    8-12 minutes

  • Central venous pressure (mmHg)

    8-12 minutes

  • +5 more secondary outcomes

Study Arms (3)

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: EchocardiographyDiagnostic Test: Right side catheterizationDiagnostic Test: Exercise testDiagnostic Test: Holter monitor

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: EchocardiographyDiagnostic Test: Right side catheterizationDiagnostic Test: Exercise testDiagnostic Test: Holter monitor

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: EchocardiographyDiagnostic Test: Right side catheterizationDiagnostic Test: Exercise testDiagnostic Test: Holter monitor

Interventions

EchocardiographyDIAGNOSTIC_TEST

Standard echocardiography.

ASD patients with surgical closureASD patients with transcatheter closureControls
Right side catheterizationDIAGNOSTIC_TEST

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

ASD patients with surgical closureASD patients with transcatheter closureControls
Exercise testDIAGNOSTIC_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.

ASD patients with surgical closureASD patients with transcatheter closureControls
Holter monitorDIAGNOSTIC_TEST

Holter monitor worn for 2 whole days registering heart rate.

ASD patients with surgical closureASD patients with transcatheter closureControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital

Aarhus, Denmark

Location

Related Publications (2)

  • Karunanithi Z, Andersen MJ, Mellemkjaer S, Alstrup M, Waziri F, Skibsted Clemmensen T, Elisabeth Hjortdal V, Hvitfeldt Poulsen S. Elevated Left and Right Atrial Pressures Long-Term After Atrial Septal Defect Correction: An Invasive Exercise Hemodynamic Study. J Am Heart Assoc. 2021 Jul 20;10(14):e020692. doi: 10.1161/JAHA.120.020692. Epub 2021 Jul 14.

    PMID: 34259012DERIVED

  • Alstrup M, Karunanithi Z, Maagaard MO, Poulsen SH, Hjortdal VE. Sympathovagal imbalance decades after atrial septal defect repair: a long-term follow-up study. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):83-89. doi: 10.1093/ejcts/ezab235.

    PMID: 34015096DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Heart Septal Defects, AtrialHypertension, PulmonaryHeart Defects, Congenital

Interventions

EchocardiographyExercise TestElectrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Septal DefectsCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesElectrocardiographyElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Zarmiga Karunanithi, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 21, 2018

Study Start

August 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

May 6, 2021

Record last verified: 2019-06

Locations

DK(1)