The primary objective is to correlate the properties of the right ventricular strain-area loop to the properties of the right ventricular pressure-volume curve.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the correlation between the different measures
for contractility and compliance from the strain-area loop and the
pressure-volume loop.
• The relation between the end-systolic pressure-volume relationship (ESPVR)
the slope of the systolic part of the strain-area loop (Sslope).
• The relation between the end-diastolic pressure-volume relationship (EDPVR)
the slope of the diastolic part of the strain-area loop during passive filling.
Secondary outcome
• dP/dT of the pressure-volume loop
• de maximale eind-systolische strain
Background summary
Pulmonary arterial hypertension (PAH) is a progressive disease, with a mean
4-year survival rate of 50 a 60%. In PAH patients a increase resistance in the
pulmonary artery is present, forcing the right ventricle to produce increased
pressure to circulate the same amount of blood. Due to this the right ventricle
often dilates and becomes hypertrophic which in the end results in right sided
heart failure. To diagnose PAH a right (and left) heart catheterisation is used
to measure the pressure in the pulmonary artery. This measurement plays an
important part in the diagnosis of PAH. A big disadvantage of this technique is
its invasive nature and the lack of information of the right ventricular
function it provides. Due to the risks involved (due to its invasive nature) in
this technique, repeated measures are not usual performed. A non-invasive
alternative which provides comparable information has big advantages.
The introduction of Speckle tracking echocardiography provides the opportunity
to measure ventricular wall deformation (so called strain). By combining
concomitant temporal echcardiographic measures of strain (function) and
volume/area (structure) of the ventricles a strain-area loop can be
constructed. With this strain-area loop it is possible to measure hemodynamical
changes in the heart. The strain-area loop might be able to provide comparable
information as the invasive measured pressure-volume loop.
Study objective
The primary objective is to correlate the properties of the right ventricular
strain-area loop to the properties of the right ventricular pressure-volume
curve.
Study design
This will be an prospective, exploratory study
Study burden and risks
The included patients are already scheduled to recieve a catheterization and
will be asked in advantage whether they want to participate in this study. In
case of participation the patient will recieve an additional catheterization
sheath through which the balloon catheter will be inserted. This sheath will be
introduced using echo guidance and will have the same risks as the sheath used
for the catheterization itself. During the catheterization a balloon-catheter
will be inserted into the vena cava, after which this balloon will be inflated
in 3 steps. The risks associated with this procedure are minor (in an pulmonary
angiography, the risk at complication is 0.4%, while this procedure involves a
smaller vessel and higher pressures. furthermore the most common complication
is due to a contrast allergy, which is not used during the procedure in this
study). The process of the balloon inflation is immediately reverseable (by
deflating the balloon) in case any complication occurs during the procedure.
During each phase a echocardiographic image of the heart will be produced. The
additional echocardiographic images are non-invasie and not associated with any
additional risks for the patient.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
Suspected pulmonary arterial hypertension
Above 18 years
Voluntary participation
Exclusion criteria
Cardiovascular diseases, other than pulmonary arterial hypertension
Diabetes Mellitus
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 | NL61716.091.17 |