Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.
PROMETEY
Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2019
CompletedFirst Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedOctober 18, 2021
September 1, 2021
3 years
August 12, 2019
October 15, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
All-cause mortality
Death of patient from all causes.
During all observational period (60 months)
Heart transplantation
Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
During all observational period (60 months).
Cardioverter-defibrillator implantation
Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
During all observational period (60 months).
Hospitalization with heart failure decompensation
Hospitalization of patient due to decompensation of heart failure.
During all observational period (60 months)
Secondary Outcomes (6)
Thromboembolism.
During all observational period (60 months).
Myocardial infarction
During all observational period (60 months).
Stroke
During all observational period (60 months).
Sudden cardiac death
During all observational period (60 months).
Surgical therapy of heart failure or arrhythmias
During all observational period (60 months).
- +1 more secondary outcomes
Study Arms (4)
cancer survivors with heart failure and/or fatal arrhythmias
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.
Cancer survivors without complications
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.
Cancer patients before chemotherapy
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.
Patients with non-toxic dilated cardiomyopathy (control).
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.
Interventions
Transthoracic echocardiography with speckle tracking analysis.
Ambulatory 48-hour electrocardiography monitoring.
Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Eligibility Criteria
Male and female more than 18 years old with verified cancer or with non-toxic dilated cardiomyopathy (control group).
You may qualify if:
- 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.
You may not qualify if:
- refusal of patient,
- sepsis,
- coma, delirium,
- mental disorders,
- left chest radiation therapy,
- metastases in central nervous system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1
Moscow, Moscow Oblast, 107095, Russia
Biospecimen
Whole blood, plasma.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yury A Vasyuk, MD
Moscow State University of Medicine and Dentistry
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 14, 2019
Study Start
June 14, 2019
Primary Completion
June 1, 2022
Study Completion
June 1, 2024
Last Updated
October 18, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share