Pulmonary Arterial HypertensionNCT06567379
Myocardial Work Evaluation in Patients With PAH
An observational study of Pulmonary Arterial Hypertension, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Right ventricular function is a key determinant of survival in patients with pulmonary arterial hypertension, with right heart failure being the leading cause of death. ERS/ESC guidelines recommend evaluating RV function at diagnosis and at first reevaluation under treatment to estimate the one-year mortality risk. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2024to 30 Sep 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: PAH patients referred to PH reference center in Nancy university Hospital
Who may be able to join
- All consecutive incident patients with a diagnosis of idiopathic, heritable, drug-associated PH, or associated with portal hypertension and referred to PH reference center in Nancy university hospital.
- Transthoracic echocardiography (TTE) and a right heart catheterization (RHC) within 48 hours at diagnosis and at first reevaluation with PAH treatment
Who cannot join
- cardiac ultrasound data not analyzable (poor echogenicity or poor quality of RV slice). - -- Patients with PH associated with left-heart disease (group 2), PH associated with lung diseases and/or hypoxia (group 3), PH associated with pulmonary artery obstructions (group 4) and PH with unclear and/or multifactorial mechanisms (group 5) were also excluded. Patients with a positive response to the vasoreactivity test or with features of venous or capillaries involvement were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Right Ventricular Myocardial Work in Patients With Pulmonary Arterial Hypertension
Right ventricular function is a key determinant of survival in patients with pulmonary arterial hypertension, with right heart failure being the leading cause of death. ERS/ESC guidelines recommend evaluating RV function at diagnosis and at first reevaluation under treatment to estimate the one-year mortality risk. However, few RV function markers address both systolic function and afterload. Noninvasive myocardial work is a promising new tool that incorporates systolic function and its afterload into global longitudinal strain. Initially developed for the left ventricle, it can be adapted for the RV using pressure-strain loops. The article aims to evaluate the association of RV myocardial work parameters with the estimate one-year mortality in patients with PAH.
This retrospective study will include patients diagnosed with PAH with transthoracic echocardiography and right heart catheterization within 48 hours at diagnosis and first reevaluation. Patients with unanalyzable echocardiography data will be excluded.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a rare hemodynamic disease characterized by pre-capillary pulmonary hypertension (PH), due to pulmonary vascular remodeling. Despite the recent development of effective therapies, right ventricular (RV) function remains a key determinant of survival as right heart failure remains the main cause of death among patients with PAH. According to ESC/ERS guidelines, RV function should be evaluated in patients with PAH at baseline (by echocardiography or cardiac MRI) to assess one-year mortality risk, thereby impacting on patient treatment. However, few RV function markers address both the systolic function of the RV and its afterload (i.e., RV-pulmonary artery coupling), which seems necessary in PAH, where the disease is characterized by a progressive increase in pulmonary artery pressures and subsequently, an alteration in RV systolic function. Noninvasive myocardial work is a promising new tool for the evaluation of RV systolic function developed to help differentiate reduced myocardial performance due to increased afterload versus reduced myocardial contractibility. It was first developed for left ventricular assessment but can be adapted to the RV using pressure-strain loops. Very few data on its use on RV function are available but the results are promising. However, its value in patients with PAH and its evolution after PAH treatment initiation has never been evaluated. Thus, the aim of this article is to evaluate the association of RV myocardial work parameters at baseline and at first reevaluation with estimated one-year mortality risk in patients with PAH.
- Conditions
- Pulmonary Arterial Hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PAH patients | Patients with heritable, idiopathic PAH or PAH associated with portal hypertension or with drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year risk mortality
According to four model strata, estimation of one year mortality risk (low, intermediate-low, intermediate-high or high risk)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start25 Jul 2024
- Primary completion25 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567379
- Sponsor's protocol ID
- 2024PI
- Status last verified
- Jun 2024
- First submitted
- 20 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Right Ventricular Myocardial Work in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06567379
- Acronym / sponsor ID
- 2024PI
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
Right ventricular function is a key determinant of survival in patients with pulmonary arterial hypertension, with right heart failure being the leading cause of death. ERS/ESC guidelines recommend evaluating RV function at diagnosis and at first reevaluation under treatment to estimate the one-year mortality risk. However, few RV function markers address both systolic function and afterload. Noninvasive myocardial work is a promising new tool that incorporates systolic function and its afterload into global longitudinal strain. Initially developed for the left ventricle, it can be adapted for the RV using pressure-strain loops. The article aims to evaluate the association of RV myocardial work parameters with the estimate one-year mortality in patients with PAH.
This retrospective study will include patients diagnosed with PAH with transthoracic echocardiography and right heart catheterization within 48 hours at diagnosis and first reevaluation. Patients with unanalyzable echocardiography data will be excluded.
Detailed description
Pulmonary arterial hypertension (PAH) is a rare hemodynamic disease characterized by pre-capillary pulmonary hypertension (PH), due to pulmonary vascular remodeling. Despite the recent development of effective therapies, right ventricular (RV) function remains a key determinant of survival as right heart failure remains the main cause of death among patients with PAH. According to ESC/ERS guidelines, RV function should be evaluated in patients with PAH at baseline (by echocardiography or cardiac MRI) to assess one-year mortality risk, thereby impacting on patient treatment. However, few RV function markers address both the systolic function of the RV and its afterload (i.e., RV-pulmonary artery coupling), which seems necessary in PAH, where the disease is characterized by a progressive increase in pulmonary artery pressures and subsequently, an alteration in RV systolic function. Noninvasive myocardial work is a promising new tool for the evaluation of RV systolic function developed to help differentiate reduced myocardial performance due to increased afterload versus reduced myocardial contractibility. It was first developed for left ventricular assessment but can be adapted to the RV using pressure-strain loops. Very few data on its use on RV function are available but the results are promising. However, its value in patients with PAH and its evolution after PAH treatment initiation has never been evaluated. Thus, the aim of this article is to evaluate the association of RV myocardial work parameters at baseline and at first reevaluation with estimated one-year mortality risk in patients with PAH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAH patients | – | –Patients with heritable, idiopathic PAH or PAH associated with portal hypertension or with drugs. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- PAH patients referred to PH reference center in Nancy university Hospital
Key inclusion criteria (2 listed)
- All consecutive incident patients with a diagnosis of idiopathic, heritable, drug-associated PH, or associated with portal hypertension and referred to PH reference center in Nancy university hospital.
- Transthoracic echocardiography (TTE) and a right heart catheterization (RHC) within 48 hours at diagnosis and at first reevaluation with PAH treatment
Key exclusion criteria (1 listed)
- cardiac ultrasound data not analyzable (poor echogenicity or poor quality of RV slice). - -- Patients with PH associated with left-heart disease (group 2), PH associated with lung diseases and/or hypoxia (group 3), PH associated with pulmonary artery obstructions (group 4) and PH with unclear and/or multifactorial mechanisms (group 5) were also excluded. Patients with a positive response to the vasoreactivity test or with features of venous or capillaries involvement were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
One year risk mortality
Time frame: six months
According to four model strata, estimation of one year mortality risk (low, intermediate-low, intermediate-high or high risk)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Central Hospital, Nancy, France 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Valentin, M.D. (+33383153405, s.valentin@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year risk mortality (time frame: six 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 28 Aug 2024.