Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05090228 |
| Other study ID # |
NL53771.041.15 |
| Secondary ID |
15-448/M |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2016 |
| Est. completion date |
June 1, 2020 |
Study information
| Verified date |
October 2021 |
| Source |
UMC Utrecht |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study investigates damage of the right cardiac chamber in adult patients with a
congenital heart defect involving the pulmonary valve (the heart valve between the right
cardiac chamber and the lungs). The investigators want to investigate if novel, less invasive
techniques are feasible to assess damage of this right cardiac chamber, to improve follow-up
and timing of intervention (valve replacement) in this group of patients.
Description:
Rationale:
In congenital heart disease the right heart is often affected, in contrast to acquired heart
disease where the left ventricle and left sided valves are most often affected. In congenital
patients, the right heart problem is most common linked to dysfunction of the pulmonary
valve. In these congenital patients, with defects such as Tetralogy of Fallot (ToF), Double
Outlet Right Ventricle (DORV), Pulmonary Valve Atresia, and Ventricular Septum Defect (VSD),
the primary origin of the problem are dysplastic Pulmonary Valves (PV) and Right Ventricle
Outflow Tract Obstruction (RVOTO). Often these valves or obstructions are excised to be
replaced directly or in a later stage. Until the end '90s common therapy was to cut out the
pulmonary valve and leave patients without pulmonary valve for 10 to 20 years. This resulted
in a pendular flow between right ventricle and pulmonary arteries. This works because the
pulmonary vascular resistance is low and therefore inflow is easy. There is also a congenital
group in which the primary problem was left sided, but a right-sided problem is created by
therapy. Since 20 years the Ross procedure is used for congenital aortic valve stenosis. The
pulmonary valve is used in childhood to replace the aortic valve, and needs to be replaced in
adolescence by a homograft (graft with human donor valve).
In both these groups (repeat) pulmonary valve replacement is necessary, at some stage, with
an open procedure; Pulmonary Valve Replacement (PVR) or catheter procedure; Percutaneous
Pulmonary Valve Insertion (PPVI), a method available since 2000. Because these valves only
last for 10 to 20 years, timing of intervention is very important.
The last 10 years efforts have been done to delineate the best moment for pulmonary valve
replacement. The aim is to prevent right ventricular failure due to pressure overload
(stenosis of homograft), volume overload (absence of PV after excision or insufficiency of
homograft) or a combination of pressure- and volume-overload, which is believed to be most
malignant. In the past emphasis was paid to onset of symptoms instead of preventing right
ventricular damage. Because symptoms in right ventricular failure are linked to the 'point of
no return' (when the right ventricle doesn't fully recover after pulmonary valve
replacement), most likely a better strategy is to intervene before symptoms arise. To be able
to make reliable criteria for valve replacement we need to better understand the anatomical
and functional impairments of the right ventricle and link this to histopathological changes.
The investigators believe myocardial fibrosis is correlated to this 'point of no return'. In
the last decades knowledge concerning RV volumes and function, electrocardiographic and
exercise capacity has grown. But, the relation between volumes, function and histopathology
is missing.
Objective:
Primary objectives: to investigate functional and histopathological changes of the right
ventricle before and after PVR or PPVI. To investigate if non-invasive assessment of
RV-remodeling including CMR-T1rho mapping is possible and validate this with the golden
standard of histopathology.
Secondary objectives: to investigate changes in parameters, using echocardiography,
electrocardiography, biomarkers, exercise capacity and quality of life in patients undergoing
PVR or PPVI.
