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出境医 / 临床实验 / Acute Decompensation of Pulmonary Hypertension (PROPULS)

Acute Decompensation of Pulmonary Hypertension (PROPULS)

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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Biomarkers Other: A biobank will be created from blood samples taken at admission, days 3 and days 7 Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
Arm Intervention/treatment
Patients with Pulmonary arterial hypertension
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
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)
Outcome Measures
Primary Outcome Measures :
  1. time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit [ Time Frame: 90 days ]
    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 :
  1. Survival time without graft or circulatory assistance [ Time Frame: 1 month ]
    Survival without transplantation or circulatory assitance at 1 month

  2. Survival time without transplantation or circulatory assitance [ Time Frame: 12 months ]
    Survival ithout transplantation or circulatory assitance at 12 month


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: SAVALE Laurent, MD, PhD 01 45 21 79 74 laurent.savale@aphp.fr

Locations
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France
SAVALE Laurent Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: SAVALE Laurent, PHD    01 45 21 79 74    laurent.savale@aphp.fr   
Contact: SAVALE Laurent         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: SAVALE Laurent, MD, PhD Assistance Publique - Hôpitaux de Paris
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE September 19, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		time to death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit [ Time Frame: 90 days ]
The primary endpoint is a composite endpoint including death, circulatory assistance or emergency transplantation within 90 days following admission to intensive care unit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Survival time without graft or circulatory assistance [ Time Frame: 1 month ]
    Survival without transplantation or circulatory assitance at 1 month
  • Survival time without transplantation or circulatory assitance [ Time Frame: 12 months ]
    Survival ithout transplantation or circulatory assitance at 12 month
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Decompensation of Pulmonary Hypertension
Official Title  ICMJE Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hypertension, Pulmonary
  • Biomarkers
Intervention  ICMJE 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)
Study Arms  ICMJE Patients with Pulmonary arterial hypertension
Pulmonary arterial hypertension or non-operable chronic thromboembolic pulmonary hypertension established by right cardiac catheterization prior to inclusion in the study
Intervention: Other: A biobank will be created from blood samples taken at admission, days 3 and days 7
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SAVALE Laurent, MD, PhD 01 45 21 79 74 laurent.savale@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926572
Other Study ID Numbers  ICMJE APHP180273
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: SAVALE Laurent, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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