The Effect of Renin-Angiotensin System Inhibition on Aortic Dilatation Rate in Patients with Coarctation of the Aorta.

Suspended

• Conditions: Aortic coarctation; narrowing of the aorta; 10010394

• Registration Number: NL-OMON48859
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Subject has been diagnosed with CoA.
- Subject has previously undergone a surgical or transcatheter (balloon dilatation or stenting) intervention for CoA.
- A previous CMR has been performed on the subject.
- Subject is at least 16 years of age.
- Subject is competent to understand the performed procedures, the potential hazards associated with these procedures, and to provide written informed consent.

Exclusion Criteria

- Subject with thoracic aortic dissection prior to study period.
- Subject who underwent an intervention for an aneurysm of the ascending aorta prior to study period.
- Subject is currently pregnant or has been pregnant during the study period.
- Subject has a medical condition which, in the opinion of the investigator, could adversely affect the subject*s safety and/or the interpretation of the results.
- Subject with a contraindication for CMR with administration of gadolinium-based contrast agent:
• Cardiac pacemaker or implanted cardioverter defibrillator not compatible with CMR.
• Electronic device or implant, such as cochlear implant or insulin pump.
• Past adverse reaction to gadolinium-based contrast agents.
• Severe renal insufficiency (creatinine clearance <30 mL/min/1,73 m²).
• Known claustrophobia.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>CMR:<br /><br>- Dilatation rate of the aortic root and ascending aorta (mm/year)</p><br>