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Trial record 1 of 1 for:    NCT03404492
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Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension (Rehab-HTP)

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ClinicalTrials.gov Identifier: NCT03404492
Recruitment Status : Unknown
Verified June 2018 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : January 19, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Other: Stress echocardiography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : April 12, 2019
Estimated Study Completion Date : April 12, 2019

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Arms and Interventions
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Arm Intervention/treatment
Patients with pulmonary hypertension Other: Stress echocardiography
A stress echocardiography will be performed in addition to the traditional patient care


Outcome Measures
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Primary Outcome Measures :
  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) [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404492


Contacts
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Contact: Pamela MOCERI, PH +33 (0)4.92.03.77.34 moceri.p@chu-nice.fr

Locations
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France
Hôpital Pasteur Recruiting
Nice, France, 06002
Contact: Pamela MOCERI, PH    +33 (0)4.92.03.77.34    moceri.p@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Pamela MOCERI, PH Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03404492    
Other Study ID Numbers: 17-PP-09
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases