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Active, not recruitingNCT07253363ACTIBIOUpdated Nov 28, 2025

Circulating Activin-A and FSTL3 in Precapillary Pulmonary Hypertension

An interventional study of Biological collection in Pulmonary Hypertension, sponsored by Assistance Publique - Hôpitaux de Paris. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 1 year 8 months after the study started (first participant enrolled Mar 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
550
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 (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).

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • Pulmonary Hypertension
  • biomarkers
  • FSTL3
  • Activin-A
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 550 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  1. Male or female ≥ 18 years of age
  2. 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
  3. Pulmonary arterial hypertension (group 1) or PH associated with lung disease (group 3) or chronic thromboembolic PH (group 4)
  4. Patient registered in the French PH registry
  5. Patient capable of understanding the study procedures
  6. Affiliation to a social security regime (or exemption)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
550 participants (estimated)

Study arms

  • Other
    No Intervention

    No Intervention

    Other: Biological collection

Interventions

  • OtherBiological collection

    Serum, plasma, ADN

06

What researchers measure

Primary outcomes

  1. Lung-transplant-free survival at 2 years

    The primary endpoint is time fto lung-transplantation or death within two years following inclusion

    Time frame: Two years

07

Study locations

1 site
  • Hôpital Bicêtre (AP-HP.Université Paris-Saclay), Service de Pneumologie et Soins Intensifs
    Le Kremlin-Bicêtre, France 94270, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07253363
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Mar 1, 2024
Primary completion
Apr 2026 (estimated)
Completion
Apr 2028 (estimated)
Last update
Nov 28, 2025

Study contacts

Laurent SAVALE
principal investigator · Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bicètre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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