European Registry of Acutely Decompensated Pulmonary Arterial Hypertension

NCT06923917 | Not Yet Recruiting DMC

• 1 other identifier: APHP250036
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Acute decompensation of pulmonary hypertension (PH) is associated with a very unfavorable short-term prognosis. However, the development of circulatory support techniques and the possible use of emergency transplantation in recent years has significantly changed the management of patients with refractory right ventricular failure. Nonetheless, there are significant disparities in the management of these patients depending on the organization of the care pathway, the rules for graft allocation, and access to circulatory support across European countries. Moreover, the implementation of these new therapeutic strategies requires the identification of effective prognostic factors and the development of new monitoring techniques. The objective of this collaborative clinical research project is to study the prognostic implications of acute decompensated right heart failure associated with PAH based on a large-scale European multicenter approach using a prospective analysis of clinical, biological, and echocardiographic data.

Conditions

Pulmonary Hypertension

Keywords

pulmonary arterial hypertension; Right heart failure; intensive care; extracorporal life support; transplantation

Outcome Measures

Primary Outcomes (1)

• 3-months mortality/lung transplantation

  3-months mortality/lung transplantation

  3-months post inclusion

Secondary Outcomes (5)

• 12-months mortality/lung transplantation

  12 months most inclusion

• Rehospitalization for acute decompensation of PAH within 12 months following inclusion

  Within 12 months after inclusion

• Proportion of patients treated with catecholamines, placed on ECMO, and transplanted in each center

  Within 12 months post inclusion

• Mortality at 3 months following circulatory support

  3 months post inclusion

• 3 and 12-month mortality/lung transplantation in pediatric patients

  3 and 12 months post inclusion

Study Arms (1)

Patient with a confirmed diagnosis of pulmonary arterial hypertension managed for acute right hear

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized with a confirmed diagnosis of pulmonary arterial hypertension (group 1) according to the latest European guidelines of 2022

You may qualify if:

• Patients with established diagnosis of pulmonary arterial hypertension (group 1) according to the 2022 ESC/ERS guidelines.
• Worsening of clinical signs of right heart failure in the month prior to hospital admission requiring the use of:
• intravenous diuretic therapy for ≥ 2 days
• or inotropes
• or vasopressors

You may not qualify if:

• Patients with non-group 1 pulmonary hypertension
• Shock due to a cause other than right heart failure
• Person unable to provide written informed consent (person deprived of liberty by judicial or administrative decision)
• Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice)
• Person under psychiatric care
• Patient's objection to the use of their data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• European Respiratory Society: collaborator

Study Sites (1)

Assistance Publique hopitaux de Paris

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Central Study Contacts

Laurent Savale, MD PHD

CONTACT

+33 1 45 21 79 74; laurent.savale@aphp.fr

Hifsa Khan Abdul

CONTACT

hifsa.khanabdul@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)