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Clinical Trials/NCT01905189
NCT01905189
Unknown
Not Applicable

Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

University Hospital, Caen1 site in 1 country15 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
University Hospital, Caen
Enrollment
15
Locations
1
Primary Endpoint
cardiac index measured during right catheterization
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
June 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

cardiac index measured during right catheterization

Time Frame: After two minutes of right stimulation

Study Sites (1)

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