Acute Decompensation of Pulmonary Hypertension

Assistance Publique - Hôpitaux de Paris145 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

145

Conditions

Hypertension, Pulmonary Biomarkers

Interventions

A biobank will be created from blood samples taken at admission, days 3 and days 7OTHER

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SAVALE Laurent

Le Kremlin-Bicêtre, France

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

Survival time without graft or circulatory assistance

Survival without transplantation or circulatory assitance at 1 month

Time frame: 1 month

Survival time without transplantation or circulatory assitance

Survival ithout transplantation or circulatory assitance at 12 month

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.