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

Primary Purpose

Pulmonary Arterial Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Resynchronization therapy of right ventricle

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, cardiac resynchronization therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Caen UHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemodynamic study, cardiac pacing

Arm Description

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.

Outcomes

Primary Outcome Measures

cardiac index measured during right catheterization

Secondary Outcome Measures

Full Information

NCT ID

NCT01905189

First Posted

July 18, 2013

Last Updated

April 8, 2014

Sponsor

University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT01905189

Brief Title

Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Acronym

RETRIEVE

Official Title

Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Caen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension, cardiac resynchronization therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hemodynamic study, cardiac pacing

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Resynchronization therapy of right ventricle

Intervention Description

Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy

Primary Outcome Measure Information:

Title

cardiac index measured during right catheterization

Time Frame

After two minutes of right stimulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul-Ursmar Milliez, MD, PhD

Phone

+33231065118

milliez-p@chu-caen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul-Ursmar Milliez

Organizational Affiliation

Caen UH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Caen UH

City

Caen

State/Province

Basse-Normandie

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul-Ursmar Milliez

Phone

+33231065118

milliez-p@chu-caen.fr

First Name & Middle Initial & Last Name & Degree

Arnaud Pellissier

Phone

+33231065118

pellissier-a@chu-caen.fr

First Name & Middle Initial & Last Name & Degree

Arnaud Pellissier

First Name & Middle Initial & Last Name & Degree

Paul-Ursmar Milliez

First Name & Middle Initial & Last Name & Degree

Sophie Gomes

First Name & Middle Initial & Last Name & Degree

Emmanuel Bergot

First Name & Middle Initial & Last Name & Degree

Farzin Beygui

First Name & Middle Initial & Last Name & Degree

Fabien Labombarda

First Name & Middle Initial & Last Name & Degree

Alain Lebon

First Name & Middle Initial & Last Name & Degree

Vincent Roule

First Name & Middle Initial & Last Name & Degree

Rémi Sabatier

First Name & Middle Initial & Last Name & Degree

Eric Saloux

First Name & Middle Initial & Last Name & Degree

Patrice Scanu

First Name & Middle Initial & Last Name & Degree

Laure Champ-Rigot

12. IPD Sharing Statement

Learn more about this trial

Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

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