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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stress echocardiography
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Pasteur

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with pulmonary hypertension

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
August 28, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT03404492
Brief Title
Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
Acronym
Rehab-HTP
Official Title
Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
July 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with pulmonary hypertension
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Stress echocardiography
Intervention Description
A stress echocardiography will be performed in addition to the traditional patient care
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela MOCERI, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France

12. IPD Sharing Statement

Learn more about this trial

Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

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