Prognosis in Adult Patients with Congenital Heart Disease (PRO-ACHD)

December 4, 2024 updated by: Graziani Francesca, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pazients with congenital heart disease either untreated, corrected or palliated evaluated for the first time in our ACHD Oupatient Clinic during the study period

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ACHD cohort
Adult patients with congenital heart disease either untreated, corrected or palliated, evaluated in our ACHD Outpatient Clinic between 2014 and 2026 with at least one-year follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular outcomes
Time Frame: 5 years
composite endpoint of death and cardiac hospitalization
5 years
major cardiac arrhytmias
Time Frame: 5 years
occurence of ventricular and/or atrial arrhythmias
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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