Acute Decompensation of Pulmonary Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension

Conditions
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Hypertension, Pulmonary, Biomarkers

Intervention / Treatment
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* Other: A biobank will be created from blood samples taken at admission, days 3 and days 7


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension with samples of blood samples taken at admission, days 3 and 7 in the context of this clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Pulmonary arterial hypertension<br>Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study | Other: A biobank will be created from blood samples taken at admission, days 3 and days 7<br>* A biobank will be created from the blood samples taken on admission, days 3 and 7 of admission. The prognostic value of the preselected biomarkers will be analyzed and a proteomic analysis will be performed to identify new biomarkers. The prognostic value of these new biological parameters will be compared to the usual surveillance parameters that will be collected during the follow-up (clinical, echocardiographic and hemodynamic parameters)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit | The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time without graft or circulatory assistance | Survival without transplantation or circulatory assitance at 1 month | 1 month | 
| Survival time without transplantation or circulatory assitance | Survival ithout transplantation or circulatory assitance at 12 month | 12 months |