GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03672123

Enrollment

270

Registered

2018-09-14

Start date

2018-09-17

Completion date

2023-06-30

Last updated

2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Poland

Outcome results