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Transposition of Great VesselsEPOCH-ASONCT04335448

Comprehensive Long-term Follow up of Adults With Arterial Switch Operation

An observational study of Transposition of Great Vessels, run by University of Zurich at 11 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Background: Long-term outcomes in adults with prior arterial switch operation (ASO) have not yet been well defined. The aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their ASO. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Transposition of Great Vessels
How many people
540 participants
Where
11 sitesin 5 countries
Study dates
1 Oct 2019to 30 Sep 2039
How long will I take part?
20 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Adults (≥16 years) with transposition of great arteries or a Taussig-Bing anomaly who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled. Exclusion criteria are incapability of giving informed consent and previous heart transplant.

Who may be able to join

  • Adults (≥16 years)
  • with transposition of great arteries or a Taussig-Bing anomaly
  • who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled.

Who cannot join

  • Incapability of giving informed consent and previous heart transplant.

Trial locations and contacts

11 sites in 5 countries.

11 sites in 5 countries

Switzerland5 sites

  • University Hospital Basel

    Basel

  • University Hospital Inselspital Bern

    Bern

  • University Hospital Geneva

    Geneva

  • University Hospital Lausanne

    Lausanne

  • University Hospital Zurich

    Zurich

Other trials in Switzerland

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Universitario y Politécnico La Fe Valencia

    Valencia

Other trials in Spain

Austria1 site

  • University Hospital Vienna

    Vienna

Other trials in Austria

France1 site

  • CHU Paris IdF Ouest - HEGP Hôpital Européen Georges Pompidou

    Paris

Other trials in France

Netherlands1 site

  • Amsterdam University Medical Center

    Amsterdam

Other trials in Netherlands

About this study

Official title: Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease

Background: Long-term outcomes in adults with prior arterial switch operation (ASO) have not yet been well defined. The aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their ASO.

Methods: The comprehensive long-term follow up of adults with ASO is a project within the European collaboration for prospective outcome research in congenital heart disease (EPOCH). It is designed as a prospective, international multicenter cohort study. Consecutive patients (aged 16 years or more) with prior ASO will be included at 11 European tertiary care centers. Participants will be followed according to a standardized protocol following international recommendations, including standardized protocols for imaging and for exercise testing. Main outcome measures are all-cause and cardiac-related mortality, rate of cardiac re-intervention, neo-aortic dissection, myocardial infarction, stroke, infective endocarditis, sustained atrial and ventricular arrhythmias, new-onset or worsening pulmonary hypertension and new-onset heart failure. Secondary endpoints are frequency and progression of right ventricular outflow tract stenosis, neo-aortic root dilatation, neo-aortic valve regurgitation and ventricular dysfunction. The impact of demographic, anatomic (e.g. coronary artery anatomy) and functional variables on the above-mentioned outcomes, as well as quality of life and incidence of pregnancy related complications will also be assessed.

Aim: The prospective, international, multicenter EPOCH-ASO study will provide a better understanding of adverse outcomes and their predictors in adults after ASO. The results of the EPOCH-ASO study may help to optimize future care of this novel patient cohort in adult cardiology.

Being tested
No intervention is planed
Keywords
transposition of the great arteries, arterial switch operation, coronary artery anomaly, outcome
Medical subject headings
Transposition of Great Vessels

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention is planedOther

    No intervention is planed

Study groups in NCT04335448
Study groupRoleWhat they receive
Arterial Switch Operation - Transposition of Great ArteriesPatients with previous arterial switch operation for the treatment of a transposition of great arteries will constitute the sole group of the cohort.
Receives: Other: No intervention is planed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all-cause mortality

    Determination of cause of death

    Measured: during a follow up of up to 20 years

  2. Incidence of cardiac-related mortality

    Sudden cardiac death (death that ensues unexpected within one hour of onset of symptoms), death related to acute myocardial infarction, death that is primarily caused by heart failure or death within 30 days or during the hospital admission after a cardiac intervention.

    Measured: during a follow up of up to 20 years

  3. Incidence/rate of re-intervention

    Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.

    Measured: during a follow up of up to 20 years

  4. Incidence/rate of neo-aortic dissection

    Aortic dissection with entry within the neo-aortic root.

    Measured: during a follow up of up to 20 years

  5. Incidence of myocardial infarction

    Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.

    Measured: during a follow up of up to 20 years

  6. Incidence of arrhythmias

    Atrial arrhythmias with a duration of >30 seconds, or requiring anti-arrhythmic medication or ablation procedures and / or sustained ventricular tachycardia (heart rate >100/min) for at least 30 seconds or requiring electrical cardioversion / defibrillation.

    Measured: during a follow up of up to 20 years

  7. Incidence of new onset / worsening heart failure

    Hospital admission for heart failure or initiation of heart failure medication for symptoms of heart failure (excludes initiation of medication for asymptomatic deterioration of ventricular function), according to the current guidelines of the European Society of Cardiology.

    Measured: during a follow up of up to 20 years

  8. Incidence of stroke

    Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.

    Measured: during a follow up of up to 20 years

  9. Incidence of infective endocarditis

    Defined according to the modified Duke's criteria, according to the current ESC guidelines.

    Measured: during a follow up of up to 20 years

  10. Incidence of pulmonary hypertension

    Defined as an increase in mean pulmonary arterial pressure (PAPm) ≥20 mmHg at rest as assessed by right heart catheterization.

    Measured: during a follow up of up to 20 years

Secondary outcomes (13)

  1. Rate of right ventricular outflow tract stenosis

    At least 1 of the following criteria:

    • Branch pulmonary artery minimal diameter: maximal diameter at least 1:2 on CT or MRI
    • Echocardiographic systolic peak gradient across branch pulmonary arteries > 16mmHg (peak velocity > 2.0m/s)
    • Estimated right ventricular systolic pressure > 40mmHg (determined by RV/RA-pressure gradient and estimated central venous pressure, see echocardiography protocol for details)

    Measured: during a follow up of up to 20 years

  2. Rate of the different patterns of the coronary anatomy

    To study the impact of coronary artery anatomy and type of coronary reimplantation on cardiovascular morbidity, ventricular function and functional capacity with a specific focus on presence of coronary artery obstruction, acute proximal angulation and inter-arterial or intramural course.

    Measured: during a follow up of up to 20 years

  3. Incidence/rate of neo-aortic root dilatation

    Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.

    Measured: during a follow up of up to 20 years

  4. Incidence of progression of neo-aortic root dilatation

    Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.

    Measured: during a follow up of up to 20 years

  5. Incidence/rate of neo-aortic regurgitation

    Assessment by echocardiography:

    • Mild, moderate, severe (50)

    Assessment by CMR

    • Regurgitation fraction and volume by flow measurements in proximal aortic root.

    Measured: during a follow up of up to 20 years

  6. Incidence of progression of neo-aortic regurgitation

    Increase > 1 grade (echocardiography) Increase of regurgitant fraction >10% on CMR.

    Measured: during a follow up of up to 20 years

  7. Incidence/rate of left ventricular systolic dysfunction

    Echocardiography:

    • Left ventricular ejection fraction (LVEF) biplane Simpson <52% for men and <54% for women (33)

    CMR:

    • LVEF < 52%

    Measured: during a follow up of up to 20 years

  8. Incidence/rate of left ventricular diastolic dysfunction

    Echocardiography:

    • Defined according to the current recommendations for the evaluation of left ventricular diastolic function by the America society of echocardiography and the European association of cardiovascular Imaging.

    Measured: during a follow up of up to 20 years

  9. Incidence of worsening left ventricular function

    Decrease of LVEF >5%

    Measured: during a follow up of up to 20 years

  10. Incidence/rate of Right ventricular dysfunction

    Echocardiography:

    • At least 2 of the following
    • FAC <30%
    • TAPSE <18mm
    • TAPSE S' <10cm/s

    CMR:

    • RVEF < 50%

    Measured: during a follow up of up to 20 years

  11. Incidence of worsening right ventricular function

    Echocardiography (not valid in case of worsening tricuspid regurgitation) - At least 2 of the following:

    • Decrease in Fac > 10%
    • Decrease in TAPSE >5mm
    • Decrease in TAPSE S' >3cm/s

    CMR:

    • Decrease in RVEF >5%

    Measured: during a follow up of up to 20 years

  12. Rate of poor functional capacity

    As determined by cardiopulmonary exercise testing by measuring Lung Function (flow volume loops), oxygen consumption during exercise (VO2 max), anaerobic threshold, heart performance during exercise (O2-Heart rate)

    Measured: during a follow up of up to 20 years

  13. Incidence of pregnancy

    To study the impact of pregnancy on mortality and cardiovascular morbidity.

    Measured: during a follow up of up to 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start1 Oct 2019
  3. Primary completion30 Sep 2039 (estimated)
  4. Study completion30 Sep 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
540 participants (actual)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335448
Sponsor's protocol ID
EPOCH
Acronym
EPOCH-ASO
Status last verified
Nov 2022
First submitted
23 Mar 2020
Last updated
8 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruperti-Repilado FJ, Ladron R, Lopez-Ayala P, Gabra B, Gonzalez-Fernandez V, Engele LJ, Manso B, Bouma BJ, Gabriel H, Schwitz F, Possner M, Schwerzmann M, Rueda J, Buendia-Fuentes F, Bouchardy J, Ladouceur M, Dos-Subira L, Greutmann M, Tobler D, Gallego P. Aortic coarctation and long-term morbidity after arterial switch operation: a multicentre international cohort study. Heart. 2026 Mar 25;112(8):437-445. doi: 10.1136/heartjnl-2024-325634.

    PubMed 40701798

Questions about this trial

What is this clinical trial studying?

An observational study of Transposition of Great Vessels, run by University of Zurich at 11 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Switzerland, Spain, Austria, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of all-cause mortality (time frame: during a follow up of up to 20 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04335448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.

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