Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Overview

Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival. Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • Procedure: Resynchronization therapy of right ventricle
    • Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy

Arms, Groups and Cohorts

  • Experimental: Hemodynamic study, cardiac pacing
    • We propose to study the hemodynamic response to a temporary atrio-dual right ventricular stimulation in pulmonary arterial hypertension subjects.Patients will be is own comparator.

Clinical Trial Outcome Measures

Primary Measures

  • cardiac index measured during right catheterization
    • Time Frame: After two minutes of right stimulation

Participating in This Clinical Trial

Inclusion Criteria

  • Pulmonary hypertension type I, III, IV, V Dana Point classification – NYHA classification equal or superior to stage II – During right catetherization : cardiac index inferior or equal 2.5 L/mn/m2 and atrial pressure superior or equal 10 mmHg OR cardiac index equal or inferior to 2.2 L/mn/m2 – Optimal therapy considered by the referring specialist practioner of the patient Exclusion Criteria:

  • Minor or incapacitated adult – Pregnancy – Unability to give free and informed consent – Pulmonary hypertension type II Dana Point classification – Eisenmenger syndrome – Patent foramen ovale – Left bundle-brach block – Pulmonary hypertension exacerbation – Medical clinical situation considered inappropriate by the investigator – Patient eligible for a heart-lung transplant – Patient eligible for pulmonary endarterectomy – Patient with poor echogenicity – Filter in the inferior vena cava

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Caen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul-Ursmar Milliez, Principal Investigator, Caen UH
  • Overall Contact(s)
    • Paul-Ursmar Milliez, MD, PhD, +33231065118, milliez-p@chu-caen.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.