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Completed

NCT Number: NCT03926572

Acute Decompensation of Pulmonary Hypertension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SAVALE Laurent

Le Kremlin-Bicêtre, 94270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension

Acronym: PROPULS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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