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

Recruiting

• Conditions: Transposition of Great Arteries

• Registration Number: NCT05690854
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Outcome definition	5 years	A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy