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

IRCCS Policlinico S. Donato30 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Transposition of Great Arteries

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

RECRUITING

Outcomes

Primary Outcomes

Adverse Outcome definition

A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).

Time frame: 5 years

Central Contacts

Giulia Pasqualin, MD

CONTACT

+390252774502 giulia.pasqualin@grupposandonato.it

Data from ClinicalTrials.gov

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