To assess, by use of MRI measurements during exercise, the level of restoration of cardiac function, and to study whether excercise limitation in CTEPH patients after a hemodynamically succesful PEA is caused by an impaired RV stroke volume response…
ID
Source
Brief title
Condition
- Heart failures
- Pulmonary vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Level of restoration of right ventricle stroke volume response during
exercise
2) Level of restoration of regional blood flow after PEA
Secondary outcome
1) Relationship between the level of restoration of cardiac function and the
level of restoration of regional blood flow
2) Relationship between the level of restoration of cardiac function and the
directly postoperative observed hemodynamic improvement.
Background summary
Chronic thromboembolic pulmonary hypertension (CTEPH) results from incomplete
resolution of pulmonary thromboembolism. If left untreated, CTEPH is a
progressive disorder with a poor prognosis. Pulmonary endarterectomy (PEA)
represents the therapy of choice for patients with surgically accessible CTEPH.
PEA is associated with near-normalization of pulmonary hemodynamics in most
operated patients.
As a consequence, exercise tolerance improves significantly, however, does not
fully normalize in part of the patients. Recently, it was suggested by
echocardiography that some patients may suffer from functional limitations due
to exercise induced (residual) pulmonary hypertension. This might be the
consequence of more distally localized chronic thrombi that were not be removed
by PEA. Due to the excercised-induced pulmonary hypertension, exercise
tolerance in these patients might be limited due to a cardiac limitation.
Recently, we demonstrated, using MRI measurements during exercise, that in
patients with pulmonary arterial hypertension exercise capacity was limited due
to an impaired RV stroke volume response during exercise.
Study objective
To assess, by use of MRI measurements during exercise, the level of restoration
of cardiac function, and to study whether excercise limitation in CTEPH
patients after a hemodynamically succesful PEA is caused by an impaired RV
stroke volume response during excercise.
To study the effect of PEA on the restoration of regional blood flow.
Finally, to study the relation between the level of restoration of cardiac
function and the restoration of regional blood flow.
Study design
MRI measurements of cardiac function at rest and during submaximal excercise.
Sub-maximal exercise is defined by reaching 70% of the maximum workload
determined at a routinely performed maximal exercise test on a cycle ergometer
prior to PEA.
Asssessment of regional blood flow at rest.
To asses the level of restoration of cardiac function and regional blood flow,
the investigations will be repated after one year in patients in whom PEA did
result in near-nomalization of the pulmonary artery pressure (meanPAP * 30
mmHg).
Study burden and risks
As far as currently known, MRI has no negative impact on patient health
Gadolineum is routinely used and is considered very safe in use
Postbus 22660
1100 DD Amsterdam
Nederland
Postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Part one study: Operable CTEPH
Part two study: Patients after PEA with near-normalized pulmonary artery pressure
Exclusion criteria
Renal insufficiency (creatinin >115 umol/l)
Part one study: generally accepted contraindications for MRI
Part two study: also: residual pulmonary hypertension (mean PAP>30 mmHg)
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 | NL16461.018.07 |