NCT07253363

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Mar 2024Apr 2028

Study Start

First participant enrolled

March 1, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Expected
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Pulmonary Hypertension

Keywords

Pulmonary HypertensionbiomarkersFSTL3Activin-A

Outcome Measures

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

    Two years

Study Arms (1)

No Intervention

OTHER

No Intervention

Other: Biological collection

Interventions

Biological collectionOTHER

Serum, plasma, ADN

No Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bicêtre (AP-HP.Université Paris-Saclay), Service de Pneumologie et Soins Intensifs

Le Kremlin-Bicêtre, France, 94270, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Laurent SAVALE

    Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bicètre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

March 1, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2028

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)