To attenuate the clinical severity of right ventricular disease by electrical pacing
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: the reduction (in msec) of right-to-left delay in onset of diastole
following acute CRT as measured using tissue Doppler echocardiography.
Secondary outcome
Secondary: the improvement (in l/min) of cardiac output following acute CRT as
measured using pressure-conductance measurements in the left ventricle and
noninvasive FinaPress*, and the improvement of microcirculation following acute
CRT as measured using noninvasive SDF.
Background summary
Right ventricular disease has increasing clinical relevance, because it affects
a growing number of patients. Yet, effective therapies are lacking. We have
recently established that the clinical severity of right ventricular disease is
largely determined by electrical interventricular dyssynchrony, i.e., delay of
electrical activity between the right and left ventricles. In this study, we
aim to establish whether acute correction of this dyssynchrony by temporary
electrical pacing attenuates the clinical severity of right ventricular disease
Study objective
To attenuate the clinical severity of right ventricular disease by electrical
pacing
Study design
Acute intervention study
Intervention
acute cardiac resynchronization therapy (CRT), i.e., temporary right atrial and
right ventricular pacing immediately after routine right heart catheterization
Study burden and risks
Acute CRT will take 30-45 min (including the associated assays such as tissue
Doppler echocardiography, FinaPress*, and SDF) and will be conducted
immediately after routine right heart catheterization and coronary angiography
in the catheterization room. Thus, the subject will undergo an additional 30-45
min of study. Based on our extensive experience with temporary cardiac pacing
in the catheterization room, we do not expect adverse events form this study.
We do not aim for immediate benefit for the subject, because this study entails
temporary CRT. However, these studies can only be conducted in this patient
group (CTEPH) patients, because we have established the pathophysiological
basis and rationale of this study in this patient group. It must be noted that
chronic CRT may be considered in these patients if the present study should
prove successful. Chronic CRT may benefit CTEPH patients, in particular, those
who are ineligible for pulmonary endarterectomy or in whom pulmonary
endarterectomy has not resulted in improved functional class.
AMC, Meibergdreef 9
1105 AZ Amsterdam
Nederland
AMC, Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Adult CTEPH patients who undergo right heart catheterization to obtain hemodynamic data as part of the regular diagnostic workup to assess their eligibility for pulmonary endarterectomy
Exclusion criteria
none
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 | NL21560.018.08 |