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NCT05992337 Clinical Trial

New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Chemotherapy Effect Clinical Trial

Official title:
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05992337
Other study ID # Version_Protocol_3_5_2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date January 2025

Study information
Verified date August 2023
Source Cardiology Prague
Contact Robert Petr, MD.
Phone +420 233 336 334
Email robert.petr81@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Breast cancer - Chemotherapy with a known cardiotoxic side effect Exclusion Criteria: - Known cardiovascular disease

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sampling
Blood sample collection for mRNA determination
• Echocardiography
Echocardiography for detection of ventricular dysfunction
• Cardio MRI
MRI for early detection of myocardial impairment caused by chemotherapy
• 24-hours monitoring of ECG
Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity
• 24 hours monitoring of BP
Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

Locations
Country Name City State
Czechia Cardiology Prague Ltd Prague
Czechia Oncology Center Medicon Prague

Sponsors (3)
Lead Sponsor Collaborator
Cardiology Prague BioVendor LM, Oncology Center Medicon

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Early detection of the cardiotoxic effect of chemotherapy using new biomarkers Echocardiography and MRI detection of cardiotoxic effect of chemotherapy - dysfunction of left ventricle, arrythmias, hypertension one year follow-up.
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