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GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Sponsor
Medical University of Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT03672123
Collaborator
(none)
270
Enrollment
1
Location
45.4
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE).

    In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    270 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism
    Actual Study Start Date :
    Sep 17, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    APE with RVD

    RVD (right ventricle disfunction) defined according to ESC (European Society of Cardiology) criteria
    APE without RVD

    RVD defined according to ESC criteria

    Outcome Measures

    Primary Outcome Measures

    1. hemodynamic deterioration [assessed daily through study completion, average of 10 days]

      Hemodynamic deterioration defined according to ESC criteria as: change in blood pressure defined as: drop in systolic arterial blood pressure < 90 mmHg or at least 40 mmHg, lasting ≤ than 15 minutes

    Secondary Outcome Measures

    1. Hemorrhagic complications [assessed daily through study completion, average of 10 days]

      Major bleeding defined according to ISTH (International Society on Thrombosis and Haemostasis) criteria.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients with APE hospitalized who give written consent.
    Exclusion Criteria:

    • lack of informed consent

    • APE with symptoms lasting above 14 days before the admission

    • acute coronary syndrome, diagnosed pulmonary hypertension

    • severe valve disease

    • sepsis

    • active malignancy

    • diagnosed mitochondrial diseases

    • chronic kidney disease at least stage 4 (KDIGO)

    • pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw Warsaw Poland 02-005

    Sponsors and Collaborators

    • Medical University of Warsaw

    Investigators

    • Principal Investigator: Marta Z Skowronska, MD, Medical University of Warsaw
    • Study Director: Piotr Pruszczyk, Prof., Medical University of Warsaw

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marta Skowronska, Principal Investigator, Medical Doctor, Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT03672123
    Other Study ID Numbers:
    • GDF-15 APE
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Apr 8, 2021