NCT05992337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

September 28, 2021

Last Update Submit

August 15, 2023

Conditions

CardiotoxicityChemotherapy EffectChemotherapy Induced Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Women with breast cancer treated with chemotherapeutics without signs of cardiotoxicity

Diagnostic Test: Blood samplingDiagnostic Test: EchocardiographyDiagnostic Test: 24-hours monitoring of ECG

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity

Diagnostic Test: Blood samplingDiagnostic Test: EchocardiographyDiagnostic Test: Cardio MRIDiagnostic Test: 24-hours monitoring of ECGDiagnostic Test: 24 hours monitoring of BP

Interventions

Blood samplingDIAGNOSTIC_TEST

Blood sample collection for mRNA determination

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicityWomen with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
EchocardiographyDIAGNOSTIC_TEST

Echocardiography for detection of ventricular dysfunction

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicityWomen with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
Cardio MRIDIAGNOSTIC_TEST

MRI for early detection of myocardial impairment caused by chemotherapy

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity
24-hours monitoring of ECGDIAGNOSTIC_TEST

Diagnostic test for detection of arrhythmias as a consequence of cardiotoxicity

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicityWomen with breast cancer treated with chemotherapeutics without signs of cardiotoxicity
24 hours monitoring of BPDIAGNOSTIC_TEST

Diagnostic test for detection of hypertension as a consequence of cardiotoxicity

Women with breast cancer treated with chemotherapeutics with signs of cardiotoxicity

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer chemotherapy population
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with breast cancer

You may qualify if:

  • Breast cancer
  • Chemotherapy with a known cardiotoxic side effect

You may not qualify if:

  • Known cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiology Prague Ltd

Prague, 10100, Czechia

RECRUITING

Oncology Center Medicon

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Blood Specimen CollectionEchocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Robert Petr, MD.

CONTACT

+420 233 336 334robert.petr81@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

August 15, 2023

Study Start

September 1, 2021

Primary Completion

November 1, 2024

Study Completion

January 1, 2025

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations

CZ(2)