New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Recruiting

• Conditions: Chemotherapy Induced Systolic Dysfunction; Cardiotoxicity; Chemotherapy Effect
• Interventions: Diagnostic Test: Blood sampling; Diagnostic Test: Echocardiography; Diagnostic Test: 24-hours monitoring of ECG; Diagnostic Test: Cardio MRI; Diagnostic Test: 24 hours monitoring of BP

• Registration Number: NCT05992337
• Lead Sponsor: Cardiology Prague

Brief Summary

Early detection and thus rapid therapy of cardiotoxicity related to chemotherapy are essential for restoring cardiovascular function. The complete recovery of the cardiovascular system decreases with time to identify the presence of cardiotoxic damage. The project aims to define new biomarkers for the early detection of cardiotoxicity in patients treated with chemotherapy.

Detailed Description

The most effective approach to minimizing the consequences of cardiotoxicity of oncological treatment is its early identification, adjustment of oncological treatment (change of procedure, dose, drugs), and immediate initiation of cardiovascular therapy. However, the current standard for monitoring the cardiovascular system in cancer patients identifies cardiotoxicity only if functional impairment has already occurred, which precludes any chance of effective prevention. The aim of the project is to identify new biomarkers for the early detection of the cardiotoxic effect of chemotherapy in women with breast cancer.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-28
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-11
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Breast cancer
• Chemotherapy with a known cardiotoxic side effect

Exclusion Criteria

• Known cardiovascular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity	24 hours monitoring of BP	-
Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity	Echocardiography	-
Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity	Blood sampling	-
Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity	24-hours monitoring of ECG	-
Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity	Blood sampling	-
Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity	24-hours monitoring of ECG	-
Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity	Echocardiography	-
Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity	Cardio MRI	-

Primary Outcome Measures

Name	Time	Method
Early detection of the cardiotoxic effect of chemotherapy using new biomarkers	one year follow-up.	Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension

Trial Locations

Locations (2)

Oncology Center Medicon; 🇨🇿 Prague, Czechia

Cardiology Prague Ltd; 🇨🇿 Prague, Czechia