Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

NCT03404492 | Completed

• 1 other identifier: 17-PP-09
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with pulmonary hypertension

OTHER

Other: Stress echocardiography

Interventions

Stress echocardiography OTHER

A stress echocardiography will be performed in addition to the traditional patient care

Patients with pulmonary hypertension

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital Pasteur

Nice, 06002, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pamela MOCERI, PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: June 12, 2018
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2020
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

FR (1)