GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT03672123
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2018-09-17
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hemorrhagic complications	assessed daily through study completion, average of 10 days	Major bleeding defined according to ISTH (International Society on Thrombosis and Haemostasis) criteria.

Trial Locations

Locations (1)

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