Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy. (PROMETEY)

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    500
  • sponsor
    Moscow State University of Medicine and Dentistry
Updated on 15 February 2022
electrocardiogram
renal function
cancer
total bilirubin
stroke
absolute neutrophil count
heart failure
arrhythmia
myocardial infarction
infarct
cardiomyopathy
myocardial injury
cancer treatment
fibrosis
sudden cardiac death
dilated cardiomyopathy
heart transplantation
myocardial dysfunction

Summary

Advances in treatment have led to improved survival of patients with cancer, but have also increased morbidity and mortality due to cancer treatment side effects. Cardiotoxicity is one the most frequent side effect which may lead to premature morbidity and death among cancer survivors. The most concerning cardiovascular complications of cancer therapy is myocardial dysfunction, leading to heart failure, and fatal arrhythmias, especially those induced by QT-prolonging drugs.

PROMETEY (PROspective Multidisciplinary obsErvational Trial of cardiotoxicity in patiEnts undergoing anticancer therapy) - is Russian multicenter observational study assessing cardiotoxicity and its clinical, biochemical and genetic factors in patients on cancer therapy.

The objectives of the study are:

  • to reveal prevalence of cardiotoxic effects of cancer therapy in routine clinical practice in Russian Federation,
  • to assess contribution of these effects to mortality of patients on cancer therapy,
  • to evaluate clinical and economic consequences of cardiotoxicity in patients with cancer,
  • to develop an individualized model of cardiotoxicity risk factors based on clinical and laboratory parameters.

Patients: 400 cancer patients with toxic cardiomyopathy and 100 patients with idiopathic or family dilated cardiomyopathy.

Study duration: 60 months. All patients will undergo complex examination after signing informed consent form(ICF): physical exam, echocardiography with speckle tracking analysis, ambulatory 48-hours ECG monitoring, biochemistry, analysis of biomarkers of myocardial injury, fibrosis and inflammation.

Primary endpoint: all-cause mortality, heart transplantation, cardioverter-defibrillator implantation, hospitalization with heart failure decompensation.

Secondary endpoints:

  • thromboembolism,
  • fatal/ nonfatal myocardial infarction, stroke,
  • sudden cardiac death,
  • surgical therapy of heart failure or arrhythmias,
  • cardiovascular death,
  • all-cause mortality,
  • heart transplantation,
  • cardioverter-defibrillator implantation.

Details
Condition Cardiotoxicity, Heart Failure, Dilated Cardiomyopathy
Treatment Echocardiography with speckle tracking analysis., 48-hour ECG monitoring., Blood samples analysis.
Clinical Study IdentifierNCT04055636
SponsorMoscow State University of Medicine and Dentistry
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

written informed consent form (ICF)
Eastern Cooperative Oncology Group (ECOG) scale 0-3
patients with verified cancer on or planned to be on chemotherapy including anthracyclines
sufficient bone marrow function, including: absolute neutrophils > 1.5 _10^9/l, platelets > 100_10^9/l, hemoglobin > 9 g/dl
sufficient liver function, including: total bilirubin < 1.5upper normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 upper normal value
sufficient renal function, including: creatinine clearance > 50 ml/min
For control group
verified non-toxic dilated cardiomyopathy

Exclusion Criteria

refusal of patient
sepsis
coma, delirium
mental disorders
left chest radiation therapy
metastases in central nervous system
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