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Acute Decompensation of Pulmonary Hypertension (PROPULS)

Primary Purpose

Hypertension, Pulmonary, Biomarkers

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
A biobank will be created from blood samples taken at admission, days 3 and days 7
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SAVALE Laurent

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with Pulmonary arterial hypertension

Arm Description

Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival time without graft or circulatory assistance
Survival without transplantation or circulatory assitance at 1 month
Survival time without transplantation or circulatory assitance
Survival ithout transplantation or circulatory assitance at 12 month

Full Information

First Posted
April 15, 2019
Last Updated
September 11, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03926572
Brief Title
Acute Decompensation of Pulmonary Hypertension
Acronym
PROPULS
Official Title
Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Biomarkers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Pulmonary arterial hypertension
Arm Type
Other
Arm Description
Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study
Intervention Type
Other
Intervention Name(s)
A biobank will be created from blood samples taken at admission, days 3 and days 7
Intervention Description
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)
Primary Outcome Measure Information:
Title
time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
Description
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 Outcome Measure Information:
Title
Survival time without graft or circulatory assistance
Description
Survival without transplantation or circulatory assitance at 1 month
Time Frame
1 month
Title
Survival time without transplantation or circulatory assitance
Description
Survival ithout transplantation or circulatory assitance at 12 month
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SAVALE Laurent, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
SAVALE Laurent
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France

12. IPD Sharing Statement

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Acute Decompensation of Pulmonary Hypertension

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