Exploring heart function in adults with systemic right ventricle
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application
This study looks at how well the hearts of adults with a specific heart condition called transposition of the great arteries are working compared to others, to see how this affects their overall health and exercise ability.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT05690854 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate heart function in adults diagnosed with transposition of the great arteries (TGA) by comparing the heart's performance in systemic right ventricle (SRV) patients to that of subpulmonary right ventricle and systemic left ventricle. It will also assess the relationship between SRV energetics and various patient functional parameters, including results from cardiopulmonary exercise tests and clinical outcomes such as hospitalization and arrhythmias. The study will involve patients aged 18 and older who are either admitted to a specialized heart unit or scheduled for cardiovascular magnetic resonance examinations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of either L-TGA or D-TGA who are undergoing cardiovascular magnetic resonance examinations.
Not a fit: Patients with intrabody ferromagnetic materials, non-CMR-conditional devices, claustrophobia, or who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of heart function in adults with TGA, potentially leading to improved management and treatment strategies.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies have shown promise in understanding heart function in congenital heart disease, suggesting potential for success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico San Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Pasqualin, MD
- Email: giulia.pasqualin@grupposandonato.it
- Phone: +390252774502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.