An observational study in Cardiotoxicity, Heart Failure and Dilated Cardiomyopathy, sponsored by Moscow State University of Medicine and Dentistry. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-10-18.
Sponsored by Moscow State University of Medicine and Dentistry · Observational
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:
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:
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 500 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Moscow State University of Medicine and Dentistry is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female more than 18 years old with verified cancer or with non-toxic dilated cardiomyopathy (control group).
For control group:
Exclusion Criteria:
Patients undergoing cancer therapy for the last 3-4 years with signs of heart failure and/or life-threatening arrhythmias. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Diagnostic Test: Echocardiography with speckle tracking analysis. · Diagnostic Test: 48-hour ECG monitoring. · Diagnostic Test: Blood samples analysis.
Patients undergoing cancer therapy for the last 3-4 years without signs of heart failure and/or life-threatening arrhythmias. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Diagnostic Test: Echocardiography with speckle tracking analysis. · Diagnostic Test: 48-hour ECG monitoring. · Diagnostic Test: Blood samples analysis.
Cancer patients before administered chemotherapy. Interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Diagnostic Test: Echocardiography with speckle tracking analysis. · Diagnostic Test: 48-hour ECG monitoring. · Diagnostic Test: Blood samples analysis.
Patients with non-toxic dilated cardiomyopathy. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Diagnostic Test: Echocardiography with speckle tracking analysis. · Diagnostic Test: 48-hour ECG monitoring. · Diagnostic Test: Blood samples analysis.
Transthoracic echocardiography with speckle tracking analysis.
Ambulatory 48-hour electrocardiography monitoring.
Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
All-cause mortality
Death of patient from all causes.
Time frame: During all observational period (60 months)
Heart transplantation
Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
Time frame: During all observational period (60 months).
Cardioverter-defibrillator implantation
Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
Time frame: During all observational period (60 months).
Hospitalization with heart failure decompensation
Hospitalization of patient due to decompensation of heart failure.
Time frame: During all observational period (60 months)
Thromboembolism.
Venous thromboembolism associated with cancer disease.
Time frame: During all observational period (60 months).
Myocardial infarction
Fatal/nonfatal myocardial infarction.
Time frame: During all observational period (60 months).
Stroke
Stroke
Time frame: During all observational period (60 months).
Sudden cardiac death
Sudden cardiac death associated with fatal arrhythmias.
Time frame: During all observational period (60 months).
Surgical therapy of heart failure or arrhythmias
Surgical therapy of heart failure or arrhythmias.
Time frame: During all observational period (60 months).
Cardiovascular death
Death of patient associated with cardiovascular disease.
Time frame: During all observational period (60 months).
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Moscow State University of Medicine and Dentistry