Acute Decompensation of Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Hypertension, Pulmonary; Biomarkers
• Interventions: Other: A biobank will be created from blood samples taken at admission, days 3 and days 7

• Registration Number: NCT03926572
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective of this study is to analyze the survival of a cohort of patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension and to establish the prognostic value of biomarkers.

Detailed Description

It is planned to include 150 patients over a two-year period. The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit. Patients will be treated according to the usual practice. A biobank will be created from blood samples taken at admission, days 3 and days 7. Prognostic value of pre-selected biomarkers will be analyzed and a proteomic analysis will be performed in order to identify new biomarkers. The prognostic value of these new biological parameters will be compared to the usual monitoring parameters that will be collected during follow-up (clinical, echocardiographic and haemodynamic parameters). In a second step, it will establish, using a dynamic model, the best combinations of parameters allowing to best assessment of prognosis of patients suffering from PH and hospitalized for acute right ventricular failure.

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Study Start: 2019-09-19
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-16
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Adult patients over 18 years
• Diagnosis of Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study
• Patients admitted in intensive care unit for acute decompensation of pulmonary hypertension requiring intravenous diuretic therapy ± use of inotropes or vasopressors.
• Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures

Exclusion Criteria

• Patients with post-capillary pulmonary hypertension
• Patients with pulmonary hypertension associated with chronic respiratory disease
• Patients with pulmonary hypertension with unclear/or multifactorial mechanisms
• Patients with operable chronic thromboembolic pulmonary hypertension
• Shock due to another cause than acute decompensation of pulmonary hypertension
• Pregnant women, or breast feeding women
• Adult protected person
• Person deprived of liberty
• Person admitted without consent
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Pulmonary arterial hypertension	A biobank will be created from blood samples taken at admission, days 3 and days 7	Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study

Primary Outcome Measures

Name	Time	Method
time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit	90 days	The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit

Secondary Outcome Measures

Name	Time	Method
Survival time without transplantation or circulatory assitance	12 months	Survival ithout transplantation or circulatory assitance at 12 month
Survival time without graft or circulatory assistance	1 month	Survival without transplantation or circulatory assitance at 1 month

Trial Locations

Locations (1)

SAVALE Laurent; 🇫🇷 Le Kremlin-Bicêtre, France