Pulmonary HypertensionRehab-HTPNCT03404492
Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
A study testing Stress echocardiography in people with Pulmonary Hypertension, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Stress echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2018to 5 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Stress echocardiography
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress echocardiographyOther
A stress echocardiography will be performed in addition to the traditional patient care
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary hypertension | Other | Not described Receives: Other: Stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start12 Jun 2018
- Primary completion5 Jul 2019
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela MOCERI, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404492
- Sponsor's protocol ID
- 17-PP-09
- Acronym
- Rehab-HTP
- Status last verified
- Aug 2023
- First submitted
- 12 Jan 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03404492
- Acronym / sponsor ID
- Rehab-HTP / 17-PP-09
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary hypertension | Other | Other: Stress echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress echocardiographyA stress echocardiography will be performed in addition to the traditional patient care | Other | Patients with pulmonary hypertension |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela MOCERI, PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress echocardiography in people with Pulmonary Hypertension, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.