Acute Decompensation of Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

— PROPULS  

Official title:

Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03926572
• Other study ID #: APHP180273
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: October 1, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Hypertension
• Hypertension, Pulmonary

Intervention

Other:
• A biobank will be created from blood samples taken at admission, days 3 and days 7
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)

Locations

Country	Name	City	State
France	SAVALE Laurent	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival time without graft or circulatory assistance	Survival without transplantation or circulatory assitance at 1 month	1 month
Secondary	Survival time without transplantation or circulatory assitance	Survival ithout transplantation or circulatory assitance at 12 month	12 months