NCT05690854|UnknownDMC
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)
STAR
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STAR
Sponsor study identifier
observational
30
1 country
1
Study Start
November 29, 2022
Actual (reported)Primary Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2022
Actual (reported)January 10, 2023
Actual (reported)January 19, 2023
Actual (reported)June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adverse Outcome definition
A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).
5 years
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
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.
Patients with diagnosis of L-loop transposition of great arteries (L-TGA) and D-loop transposition of great arteries (D-TGA) after atrial switch operation (ASO).
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
First Submitted
January 10, 2023
First Posted
January 19, 2023
Study Start
November 29, 2022
Actual (reported)Primary Completion
June 30, 2025
Estimated (date passed)Fibrosis, Valvular and Ventricular Function in Patients With TGA
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 25, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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