Clinical trial NCT03926572: Acute Decompensation of Pulmonary Hypertension
Official title: Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pulmonary
Biomarkers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
timeFrame: 90 days
Secondary outcomes:
measure: Survival time without graft or circulatory assistance
timeFrame: 1 month
measure: Survival time without transplantation or circulatory assitance
timeFrame: 12 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: SAVALE Laurent
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: SAVALE Laurent, MD, PhD
role: STUDY_CHAIR
References: