Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)

San Donato Group (GSD)

Status: Enrolling

Conditions: Transposition of Great Arteries

Study type: Observational

Funder types: Other

Identifiers

NCT05690854

STAR

Details and patient eligibility

About

The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Case group:

The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:

• are admitted to UNICCA, the Adult Congenital Heart Unit or
• are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution

Control group:

The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.

Exclusion Criteria:

• (case and control group)

  • Subjects with intrabody ferromagnetic material precluding subject's safety
  • Subjects with non CMR-conditional devices
  • Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality
  • Pregnant women

Trial design

30 participants in 2 patient groups

Case

Description:

The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who: * are admitted to IRCCS Policlinico San Donato, the Adult Congenital Heart Unit or * are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution

Control

Description:

The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.