Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension (RETRIEVE)

April 8, 2014 updated by: University Hospital, Caen

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse-Normandie
      • Caen, Basse-Normandie, France, 14000
        • Recruiting
        • Caen UH
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Arnaud Pellissier
        • Principal Investigator:
          • Paul-Ursmar Milliez
        • Sub-Investigator:
          • Sophie Gomes
        • Sub-Investigator:
          • Emmanuel Bergot
        • Sub-Investigator:
          • Farzin Beygui
        • Sub-Investigator:
          • Fabien Labombarda
        • Sub-Investigator:
          • Alain Lebon
        • Sub-Investigator:
          • Vincent Roule
        • Sub-Investigator:
          • Rémi Sabatier
        • Sub-Investigator:
          • Eric Saloux
        • Sub-Investigator:
          • Patrice Scanu
        • Sub-Investigator:
          • Laure Champ-Rigot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Resynchronization therapy of right ventricle
Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Paul-Ursmar Milliez, Caen UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01612-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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