Skip to main content
Clinical Trials/NCT01163422
NCT01163422UnknownNot Applicable

Long-term Right Ventricular Resynchronization Therapy for Chronic Thromboembolic Pulmonary Hypertension

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country20 target enrollmentStarted: July 2010Last updated:
Conditions
Interventions

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

Active Comparator

RVRT switched on immediately after pacemaker implant

Intervention: Implantation of 3-chamber pacemaker (Device)

Delayed RVRT

Placebo Comparator

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)

Investigators

Study Sites (1)

Loading locations...

Similar Trials