Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— RETRIEVE  

Official title:

Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01905189
• Other study ID #: 2012-A01612-41
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2013
• Last updated: April 8, 2014
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: Paul-Ursmar Milliez, MD, PhD
• Phone: +33231065118
• Email: milliez-p[@]chu-caen.fr
• Is FDA regulated: No
• Health authority: France : ANSM Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
France	Caen UH	Caen	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac index measured during right catheterization		After two minutes of right stimulation	Yes