Right Ventricular Resynchronization Therapy

Not Applicable

• Conditions: Right Ventricular Failure; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Hypertension
• Interventions: Device: Implantation of 3-chamber pacemaker

• Registration Number: NCT01163422
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Main study parameters/endpoints: (Duration of) improvements (in l/min) in cardiac output as measured using Doppler echocardiography, and functional class as measured using 6-minute walking distance (6-MWD), right and left ventricular dimensions and ejection fractions (99mTechnetium scintigraphy), biomarkers for heart failure (serum NT-proBNP levels), and quality of life (SF-36) questionnaire.

Design: Randomized, double-blind, cross-over study with 2 arms of 10 patients each (arms 1 and 2). In arm 1, RVRT is switched on immediately after pacemaker implant, is switched of in week 5, and switched on at the start of week 6 until study end (32 weeks). In arm 2, RVRT is switched at the start of week 5 after pacemaker implant until study end (32 weeks). At various follow-up visits at weeks 1, 4, 5, 6, 8, 12, 16, the main study parameters/endpoints (see previous paragraph) will be assessed.

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-07
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Last Update Submitted: 2010-07-14
• Study First Posted: 2010-07-15
• Last Update Posted: 2010-07-15
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate RVRT	Implantation of 3-chamber pacemaker	RVRT switched on immediately after pacemaker implant
Delayed RVRT	Implantation of 3-chamber pacemaker	RVRT switched on 4 weeks after pacemaker implant

Primary Outcome Measures

Name	Time	Method
Improvement in right/left ventricular synchrony measured using tissue Doppler echocardiography	within 8 months after pacemaker implantation
Increase in cardiac output measured using Doppler echocardiography and scintigraphy	within 8 months after pacemaker implantation
Increase in functional capacity measured with six-minute walking distance	within 8 months after pacemaker implantation

Secondary Outcome Measures

Name	Time	Method
Increase in well-being assessed with questionnaire	within 8 months after pacemaker implantation

Trial Locations

Locations (1)

Academic Medical Center, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands