Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

NCT01905189 | Unknown DMC

• 1 other identifier: 2012-A01612-41
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension; cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• cardiac index measured during right catheterization

  After two minutes of right stimulation

Study Arms (1)

Hemodynamic study, cardiac pacing

EXPERIMENTAL

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

Interventions

Resynchronization therapy of right ventricle PROCEDURE

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

Hemodynamic study, cardiac pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen UH

Caen, Basse-Normandie, 14000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paul-Ursmar Milliez

  Caen UH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul-Ursmar Milliez, MD, PhD

CONTACT

+33231065118; milliez-p@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

FR (1)