The aim of this study is to evaluate the effects of treatment on the exertional contractile reserve and RV-arterial coupling during exercise in CTEPH patients. Furthermore, we evaluate the effects on the exertional contractile reserve and RV-…
ID
Source
Brief title
Condition
- Heart failures
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The comparison of the rest-to-exercise response in RV contractility before- and
6 months after PEA, BPA and drug treatment.
Secondary outcome
The comparison of the rest-to-exercise response in RV-arterial coupling before-
and 6 months after PEA, BPA and drug treatment.
Background summary
Exercise tolerance and hemodynamic and right ventricular (RV) response to
exercise are often abnormal in chronic thromboembolic pulmonary hypertension
(CTEPH) patients after treatment, even when resting hemodynamics and resting RV
function are normalized.
Study objective
The aim of this study is to evaluate the effects of treatment on the exertional
contractile reserve and RV-arterial coupling during exercise in CTEPH patients.
Furthermore, we evaluate the effects on the exertional contractile reserve and
RV-arterial coupling during exercise within different therapies: pulmonary
endartectomy (PEA), balloon pulmonary angioplasty (BPA) and drug treatment.
Study design
Observational study with minimal invasive measurements in CTEPH patients;
invasive cardiopulmonary exercise test before- and 6 months after treatment.
Study burden and risks
A right heart catheterisation (RHC) and maximal cardiopulmonary exercise test
(CPET) are part of the normal clinical work-up of CTEPH patients, both pre- and
6 months post-treatment.
The burden and risks for subjects participating in this study are:
1. placement of a radial artery cannula. Placement of a radial artery cannula
can be painful, therefore the radial artery cannula will be placed under local
anaesthesia.
2. performing a 3 minute submaximal exercise protocol during the RHC. The risks
of are the same as the known risks for RHC.
3. Increased duration time of the RHC (approximately 15 minutes).
4. Two extra blood samples at the end of the exercise protocol (2ml per sample)
De Boelelaan 1117
Amsterdam 1007MB
NL
De Boelelaan 1117
Amsterdam 1007MB
NL
Listed location countries
Age
Inclusion criteria
Patients with chronic trombo-embolic pulmonary hypertension (above18 years old)
Exclusion criteria
History of left sided heart failure and/or valvular heart disease
Neuromuscular disorders preventing proper exercise testing
Arrhythmias preventing proper pressure curve recording
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 | NL53924.029.15 |