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NCT Number: NCT06723704

Prognosis in Adult Patients With Congenital Heart Disease

This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled.

The primary endopoint is to assess the clinical and echocardiographic predictors of adverse events during follow-up (death, arrhythmias, cardiac hospitalization).

The secondary endpoints are: 1) evaluation of the incidence of the singular components of the primary endpoint; 2) evaluation of the prognostic impact of acquired lesions, including valve disease not present at birth; 3) need for surgical/percutaneous interventions during follow up.

Participants will be evaluated in the context of scheduled follow-up visits in our Outpatient ACHD Clinic. No interventions/drug administration will be performed other than those required by standard clinical practice.

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Key information

Conditions

Adult Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026
  • Age ≥ 18 years

Exclusion criteria

  • Patients without congenital heart disease confirmed during the first evaluation
  • Impossibility to retrieve information about the first clinical evaluation in our clinic from our electonic datasets
  • Follow up shorter than one-year
  • Refused consent to participate to the study.

Treatment and study plan

Primary outcomes

  1. cardiovascular outcomes

    Time frame: 5 years

    composite endpoint of death and cardiac hospitalization

  2. major cardiac arrhytmias

    Time frame: 5 years

    occurence of ventricular and/or atrial arrhythmias

Secondary outcomes

  1. changes in echocardiographic parameters over time

    Time frame: 12 months

    • variations in cardiac chamber size (volumes in ml, diameters in mm);
    • variations in left ventricular function (assessed as left ventricular ejection fraction in % using the Simpson biplane method);
    • variations in right ventricular systolic function (assessed as tricuspid anular plane systolic excursion in mm).

  2. heart valve disease (new-onset or progression)

    Time frame: 12 months

    progression of pre-existing heart valve disease or new-onset valve dysfunction assessed through echocardiography

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Graziani, MD, PhD

CONTACT

[email protected]

00390630154432

Giulia Iannaccone, MD

CONTACT

[email protected]

00390630154432

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Prognosis in Adult Patients With Congenital Heart Disease: an Observational Study

Acronym: PRO-ACHD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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