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Completed

NCT Number: NCT03672123

GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

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

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Warsaw, 02-005, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. hemodynamic deterioration

    Time frame: 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 outcomes

  1. Hemorrhagic complications

    Time frame: assessed daily through study completion, average of 10 days

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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • National Science Center, Poland

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2018
Registry last updated
Oct 31, 2023

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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