Brief Title
Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.
Official Title
Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
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.
Study Type
Observational
Primary Outcome
All-cause mortality
Secondary Outcome
Thromboembolism.
Condition
Cardiotoxicity
Intervention
Echocardiography with speckle tracking analysis.
Study Arms / Comparison Groups
cancer survivors with heart failure and/or fatal arrhythmias
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
500
Start Date
June 14, 2019
Completion Date
June 2024
Primary Completion Date
June 2021
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Yury A Vasyuk, MD, +79161906122, [email protected]
Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT04055636
Organization ID
PR_01
Responsible Party
Sponsor
Study Sponsor
Moscow State University of Medicine and Dentistry
Study Sponsor
Yury A Vasyuk, MD, Principal Investigator, Moscow State University of Medicine and Dentistry
Verification Date
August 2019