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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48859
Enrollment
80
Registered
2019-04-03
Start date
2019-07-15
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic coarctation narrowing of the aorta

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
CMR: - Dilatation rate of the aortic root and ascending aorta (mm/year)

Secondary

MeasureTime frame
CMR: - Total aortic volume expansion (mL/year) - Myocardial fibrotic size by T1-mapping and LGE (% of LV myocardium) - Pulse wave velocity (m/s) - Distensibility of ascending aorta (mmHg*1) - Left and right ventricular ejection fraction (%) - Longitudinal strain in 2- and 4-chamber long-axis views (%) - Circumferential strain at apical, mid-ventricular and basal LV levels (%) - LV end-diastolic volume indexed to body surface area (mL/m2) - LV end-systolic volume indexed to body surface area (mL/m2) - LV mass indexed to body surface area (g/m2) - Septal and posterior wall thickness (cm) Transthoracic echocardiography: - Aortic diameter at the level of the aortic root (mm) - Peak-to-peak systolic pressure gradient across coarctation site (mmHg) - Peak velocity at coarctation site (m/s) - E/A ratio Exercise testing: - Peak exercise systolic blood pressure (mmHg) 24-hour ambulatory blood pressure monitoring: - Mean 24-hour systolic blood pressure (mmHg) - Mean 24-hour diastolic blood pressure (mmHg)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)