GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672123
• Other study ID #: GDF-15 APE
• Status: Completed
• Start date: September 17, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Poland	Department of Internal Medicine & Cardiology with the Centre for Management of Venous Thromboembolic Disease, Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	National Science Center, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic deterioration	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	assessed daily through study completion, average of 10 days
Secondary	Hemorrhagic complications	Major bleeding defined according to ISTH (International Society on Thrombosis and Haemostasis) criteria.	assessed daily through study completion, average of 10 days