Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— Rehab-HTP  

Official title:

Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404492
• Other study ID #: 17-PP-09
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: July 5, 2020

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 5, 2020
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• Stress echocardiography
A stress echocardiography will be performed in addition to the traditional patient care

Locations

Country	Name	City	State
France	Hôpital Pasteur	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		4 months