Our main objective is to evaluate the effect of RAS inhibition on ascending aortic dilatation rate by cardiac magnetic resonance (CMR) imaging in CoA patients, and compare this to CoA patients without RAS inhibition. As secondary objectives, we aim…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CMR:
- Dilatation rate of the aortic root and ascending aorta (mm/year)
Secondary outcome
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)
Background summary
Patients with coarctation of the aorta (CoA) are at high risk to develop an
ascending aortic aneurysm, which is associated with early mortality. Since
renin-angiotensin system (RAS) inhibitors have shown promising effects in
reducing aortic dilatation in patients with Marfan syndrome, we seek to
determine whether RAS inhibition may also prevent aneurysm formation in CoA
patients. Moreover, we are interested whether diffuse left ventricular (LV)
fibrosis can be detected in CoA patients to discriminate between different
potential mechanisms underlying LV hypertrophy in these patients.
Study objective
Our main objective is to evaluate the effect of RAS inhibition on ascending
aortic dilatation rate by cardiac magnetic resonance (CMR) imaging in CoA
patients, and compare this to CoA patients without RAS inhibition. As secondary
objectives, we aim to determine the presence and pattern of LV fibrosis by CMR
T1-mapping compared to late gadolinium enhancement (LGE) and assess whether
hemodynamic and structural parameters are associated with LV fibrosis.
Study design
Multicenter, observational, retrospective cohort study with in part
prospectively collected data. With regard to the assessment of LV fibrosis and
potentially associated parameters (i.e. secondary objectives), a
cross-sectional design is used.
Study burden and risks
CMR, transthoracic echocardiography, exercise testing, and 24-hour ambulatory
blood pressure monitoring are considered as standard of care. For study
purposes, the CMR protocol is extended by T1-mapping and LGE with
administration of gadolinium-based contrast agents. These agents have a
widespread clinical use and adverse reactions and side effects are rare. Since
pre-existent severe renal dysfunction may deteriorate after administration of
gadolinium contrast, patients a with creatinine clearance <30 mL/min/1,73 m²
will be excluded from this study. T1-mapping necessitates hematocrit
measurement and therefore a 3 mL blood sample will be drawn by venous puncture.
Using the NFU risk classification instrument, we consider the risks associated
with participation in this study as negligible.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66205.041.18 |