Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension (Rehab-HTP)

August 28, 2023 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06002
        • Hôpital Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with pulmonary hypertension
Other: Stress echocardiography
A stress echocardiography will be performed in addition to the traditional patient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Pamela MOCERI, PH, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2018

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

July 5, 2020

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-PP-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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