GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

NCT ID: NCT03672123

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-17

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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APE with RVD

RVD (right ventricle disfunction) defined according to ESC (European Society of Cardiology) criteria

No interventions assigned to this group

APE without RVD

RVD defined according to ESC criteria

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science Center, Poland

UNKNOWN

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Marta Skowronska

Principal Investigator, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Z Skowronska, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Piotr Pruszczyk, Prof.

Role: STUDY_DIRECTOR

Medical University of Warsaw

Locations

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Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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GDF-15 APE

Identifier Type: -

Identifier Source: org_study_id

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