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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Pamela MOCERI, PH | +33 (0)4.92.03.77.34 | moceri.p@chu-nice.fr |
France | |
Hôpital Pasteur | Recruiting |
Nice, France, 06002 | |
Contact: Pamela MOCERI, PH +33 (0)4.92.03.77.34 moceri.p@chu-nice.fr |
Principal Investigator: | Pamela MOCERI, PH | Centre Hospitalier Universitaire de Nice |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension, Pulmonary Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |