Cardiotoxicity, Dilated Cardiomyopathy, Heart Failure
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTEchocardiography with speckle tracking analysis.
Transthoracic echocardiography with speckle tracking analysis.
DIAGNOSTIC_TEST48-hour ECG monitoring.
Ambulatory 48-hour electrocardiography monitoring.
DIAGNOSTIC_TESTBlood samples analysis.
Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Sponsors
Moscow State University of Medicine and Dentistry
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 \< 1.5\*upper 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | During all observational period (60 months) | Death of patient from all causes. |
| Heart transplantation | During all observational period (60 months). | Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation. |
| Cardioverter-defibrillator implantation | During all observational period (60 months). | Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias. |
| Hospitalization with heart failure decompensation | During all observational period (60 months) | Hospitalization of patient due to decompensation of heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical therapy of heart failure or arrhythmias | During all observational period (60 months). | Surgical therapy of heart failure or arrhythmias. |
| Thromboembolism. | During all observational period (60 months). | Venous thromboembolism associated with cancer disease. |
| Cardiovascular death | During all observational period (60 months). | Death of patient associated with cardiovascular disease. |
| Myocardial infarction | During all observational period (60 months). | Fatal/nonfatal myocardial infarction. |
| Stroke | During all observational period (60 months). | Stroke |
| Sudden cardiac death | During all observational period (60 months). | Sudden cardiac death associated with fatal arrhythmias. |
Countries
Russia
Contacts
Primary ContactElena Y Shupenina, PhD
Outcome results
None listed