Clinical trial NCT03404492: Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
Official title: Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients with pulmonary hypertension. Rehabilitation is therefore now part of the recommendations for good practice. However, no data is available to elucidate the mechanism of this improvement: an improvement in myocardial reserve or an improvement in peripheral muscular capacity? The main objective of this study is to evaluate the difference in right ventricular contractile reserve before and after cardiorespiratory rehabilitation during stress ultrasound in pulmonary hypertension in 10 patients with pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* Major patients
* Proven pulmonary hypertension: PAPm ≥ 25mmHg, known PH
* Group 1,3,4 or 5 of the pulmonary hypertension classification
* Clinical stability \> 1 month clinically determined by clinician
* NYHA II or III class
* Signature of informed consent form following appropriate information
* Patient affiliated to the Social Security System

Exclusion Criteria:

* Associated left heart disease
* Complex congenital heart disease
* Acoustic window which does not allow the echocardiography to be performed correctly
* Permanent cardiac arrhythmia
* NYHA IV class and NYHA I class
* Inability to perform at least a minimal effort on an ergometer
* Unstabilized acute coronary syndrome
* Compensatory heart failure
* Disturbances of ventricular rhythm veins, may not be narrowed.
* Prevalence of high-risk embolic intracardiac thrombus
* Prevalence of high-risk embolic intracardiac thrombus
* Preference of a medium to high abundance peericard-like thinning.
* Venous thromboembolic venous thromboembolic disease (\> 3 months)
* Left ventricular ejector obstruction (severe and/or symptomatic)
* Persons under guardianship, under curatorship, protected by law
* Persons deprived of their liberty
* Pregnant and parturient women
* Major not able or unable to express consent
* Minors
* Inability to perform cardiac rehabilitation
* Modynamic instability
* Follow-up impossible for geographical or psychological reasons
* Inadequate command of the French language

Primary outcomes:
measure: Improvement of the subpulmonary ITS at effort >20% (presence of a right ventricular contractile reserve) defined by the improvement of the ITS or integral subpulmonary time-speed)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pamela MOCERI, PH
role: PRINCIPAL_INVESTIGATOR
References: