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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01905189
First Posted: July 23, 2013
Last Update Posted: April 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Caen
  Purpose

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.


Condition Intervention
Pulmonary Arterial Hypertension Procedure: Resynchronization therapy of right ventricle

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • cardiac index measured during right catheterization [ Time Frame: After two minutes of right stimulation ]

Estimated Enrollment: 15
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905189


Contacts
Contact: Paul-Ursmar Milliez, MD, PhD +33231065118 milliez-p@chu-caen.fr

Locations
France
Caen UH Recruiting
Caen, Basse-Normandie, France, 14000
Contact: Paul-Ursmar Milliez    +33231065118    milliez-p@chu-caen.fr   
Contact: Arnaud Pellissier    +33231065118    pellissier-a@chu-caen.fr   
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         
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Paul-Ursmar Milliez Caen UH
  More Information

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01905189     History of Changes
Other Study ID Numbers: 2012-A01612-41
First Submitted: July 18, 2013
First Posted: July 23, 2013
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by University Hospital, Caen:
pulmonary arterial hypertension
cardiac resynchronization therapy

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases