Pulmonary HypertensionACTIBIONCT07253363
Circulating Activin-A and FSTL3 in Precapillary Pulmonary Hypertension
A study testing Biological collection in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The ACTIOBIO study aims to evaluate the prognostic value of Activin-A and FSTL3 in a large cohort of patients with precapillary pulmonary hypertension, including pulmonary arterial hypertension (Group 1), pulmonary hypertension associated with lung diseases (Group 3), and chronic thromboembolic pulmonary hypertension… 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?
- Biological collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female ≥ 18 years of age
- Precapillary PH documented by right heart catheterization:
- mean pulmonary arterial pressure (mPAP) > 20 mmHg,
- pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg;
- pulmonary vascular resistance (PVR) > 2 WU
- Pulmonary arterial hypertension (group 1) or PH associated with lung disease (group 3) or chronic thromboembolic PH (group 4)
- Patient registered in the French PH registry
- Patient capable of understanding the study procedures
- Affiliation to a social security regime (or exemption)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Bicêtre (AP-HP.Université Paris-Saclay), Service de Pneumologie et Soins Intensifs
Le Kremlin-Bicêtre, France, 94270
About this study
Official title: Investigation of Circulating ACTIvin-A and FSTL3 as Prognostic and Predictive BIOmarkers in Precapillary Pulmonary Hypertension
The ACTIOBIO study aims to evaluate the prognostic value of Activin-A and FSTL3 in a large cohort of patients with precapillary pulmonary hypertension, including pulmonary arterial hypertension (Group 1), pulmonary hypertension associated with lung diseases (Group 3), and chronic thromboembolic pulmonary hypertension (Group 4).
Read the detailed description
In recent years, major advances have been achieved in understanding the cellular and molecular mechanisms underlying pulmonary arterial hypertension (PAH), a major subtype of precapillary PH. These discoveries have led to the development of novel therapeutic strategies, including agents targeting dysregulated pathways of the transforming growth factor beta (TGF-β) superfamily.
Parallel to therapeutic advances, risk stratification at diagnosis and during follow-up has become a cornerstone of PH management. Validated multidimensional tools now integrate clinical, exercise, biomarker, imaging, and hemodynamic parameters to estimate prognosis, guide initial treatment, and define therapeutic goals for follow-up. However, as new therapeutic targets emerge and influence disease trajectory, there is a growing need for novel biomarkers to refine these tools, making them less invasive and more accurate.
Beyond prognostic markers, identifying biomarkers that predict treatment response is essential to move toward precision medicine in PH. Such biomarkers would help tailor therapy to individual patient profiles and optimize long-term outcomes.
The main objective of this study is to analyze the prognostic value of Activin-A and Follistatin-like 3 (FSTL3) in a large cohort of patients with precapillary pulmonary hypertension, including pulmonary arterial hypertension (PAH, group 1), PH associated with lung disease (group 3), and chronic thromboembolic PH (group 4).
- Conditions
- Pulmonary Hypertension
- Being tested
- Biological collection
- Keywords
- Pulmonary Hypertension, biomarkers, FSTL3, Activin-A
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionOther
Serum, plasma, ADN
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Other | No Intervention Receives: Other: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung-transplant-free survival at 2 years
The primary endpoint is time fto lung-transplantation or death within two years following inclusion
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Mar 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2028 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent SAVALE, Principal investigator, Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bicètre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253363
- Sponsor's protocol ID
- APHP231330
- Other IDs
- N° IDRCB: 2023-A02244-41
- Acronym
- ACTIBIO
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- 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 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Circulating ACTIvin-A and FSTL3 as Prognostic and Predictive BIOmarkers in Precapillary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07253363
- Acronym / sponsor ID
- ACTIBIO / APHP231330
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, biomarkers, FSTL3, Activin-A
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 28 Nov 2025 (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.
The ACTIOBIO study aims to evaluate the prognostic value of Activin-A and FSTL3 in a large cohort of patients with precapillary pulmonary hypertension, including pulmonary arterial hypertension (Group 1), pulmonary hypertension associated with lung diseases (Group 3), and chronic thromboembolic pulmonary hypertension (Group 4).
Detailed description
In recent years, major advances have been achieved in understanding the cellular and molecular mechanisms underlying pulmonary arterial hypertension (PAH), a major subtype of precapillary PH. These discoveries have led to the development of novel therapeutic strategies, including agents targeting dysregulated pathways of the transforming growth factor beta (TGF-β) superfamily.
Parallel to therapeutic advances, risk stratification at diagnosis and during follow-up has become a cornerstone of PH management. Validated multidimensional tools now integrate clinical, exercise, biomarker, imaging, and hemodynamic parameters to estimate prognosis, guide initial treatment, and define therapeutic goals for follow-up. However, as new therapeutic targets emerge and influence disease trajectory, there is a growing need for novel biomarkers to refine these tools, making them less invasive and more accurate.
Beyond prognostic markers, identifying biomarkers that predict treatment response is essential to move toward precision medicine in PH. Such biomarkers would help tailor therapy to individual patient profiles and optimize long-term outcomes.
The main objective of this study is to analyze the prognostic value of Activin-A and Follistatin-like 3 (FSTL3) in a large cohort of patients with precapillary pulmonary hypertension, including pulmonary arterial hypertension (PAH, group 1), PH associated with lung disease (group 3), and chronic thromboembolic PH (group 4).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | Other | Other: Biological collectionNo Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Biological collectionSerum, plasma, ADN | Other | No Intervention |
Primary outcome
Lung-transplant-free survival at 2 years
Time frame: Two years
The primary endpoint is time fto lung-transplantation or death within two years following inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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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.
Laurent SAVALE principal investigator
Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bicètre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological collection in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris 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?
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: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lung-transplant-free survival at 2 years (time frame: Two years). 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 Nov 2025.