Long-term Right Ventricular Resynchronization Therapy for Chronic Thromboembolic Pulmonary Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography
Study Overview
Brief Summary
The purpose of this study is to determine whether cardiac resynchronization therapy with the use of an implanted electronic pacemaker reduces morbidity associated with chronic thromboembolic pulmonary hypertension
Detailed Description
Rationale: The clinical severity of right ventricular disease is largely determined by right-to-left ventricular dyssynchrony, i.e., delay of electrical activity between the right and left ventricles. Moreover, in patients with chronic thromboembolic pulmonary hypertension (CTEPH), we found that acute correction of this dyssynchrony by temporary pacing (prior to pulmonary endarterectomy, presently the therapy of choice for CTEPH) results in significant improvement in cardiac output. In this study, we aim to establish whether chronic pacing with the use of implanted pacemakers confers long-lasting improvements in cardiac output and functional class.
Objective: To study whether chronic pacing with implanted pacemakers confers long-lasting improvements in cardiac output and functional class in severely symptomatic CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.
Study design: Chronic intervention study, double-blinded, randomized, cross-over.
Study population: Adult CTEPH patients who are not eligible for pulmonary endarterectomy, or those in whom pulmonary endarterectomy has failed.
Intervention (if applicable): chronic right ventricular resynchronization therapy (RVRT), i.e., chronic right atrial, right ventricular, and left ventricular pacing with the use of implanted pacemakers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for pulmonary endarterectomy, and those in whom pulmonary endarterectomy has failed
Exclusion Criteria
- Not provided
Arms & Interventions
Immediate RVRT
RVRT switched on immediately after pacemaker implant
Intervention: Implantation of 3-chamber pacemaker (Device)
Delayed RVRT
RVRT switched on 4 weeks after pacemaker implant
Intervention: Implantation of 3-chamber pacemaker (Device)
Outcomes
Primary Outcomes
Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography
Time Frame: within 8 months after pacemaker implantation
Increase in cardiac output measured using Doppler echocardiography and scintigraphy
Time Frame: within 8 months after pacemaker implantation
Increase in functional capacity measured with six-minute walking distance
Time Frame: within 8 months after pacemaker implantation
Secondary Outcomes
- Increase in well-being assessed with questionnaire(within 8 months after pacemaker implantation)
