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

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ClinicalTrials.gov Identifier: NCT04055636
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Moscow State University of Medicine and Dentistry

Tracking Information
First Submitted Date August 12, 2019
First Posted Date August 14, 2019
Last Update Posted Date August 16, 2019
Actual Study Start Date June 14, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2019)
  • All-cause mortality [ Time Frame: During all observational period (60 months) ]
    Death of patient from all causes.
  • Heart transplantation [ Time Frame: During all observational period (60 months). ]
    Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
  • Cardioverter-defibrillator implantation [ Time Frame: During all observational period (60 months). ]
    Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
  • Hospitalization with heart failure decompensation [ Time Frame: During all observational period (60 months) ]
    Hospitalization of patient due to decompensation of heart failure.
Original Primary Outcome Measures
 (submitted: August 12, 2019)
  • All-cause mortality [ Time Frame: During all observational period (60 months) ]
    Death of patient from all causes.
  • Heart transplantation [ Time Frame: During all observational period (60 months). ]
    Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
  • Cardioverter-defibrilllator implantation [ Time Frame: During all observational period (60 months). ]
    Implantation of cardioverter-defibrillator implantation associated with life-threatening ventricular arrhythmias.
  • Hospitalization with heart failure decompensation [ Time Frame: During all observational period (60 months) ]
    Hospitalization of patient due to decompensation of heart failure.
Change History Complete list of historical versions of study NCT04055636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 12, 2019)
  • Thromboembolism. [ Time Frame: During all observational period (60 months). ]
    Venous thromboembolism associated with cancer disease.
  • Myocardial infarction [ Time Frame: During all observational period (60 months). ]
    Fatal/nonfatal myocardial infarction.
  • Stroke [ Time Frame: During all observational period (60 months). ]
    Stroke
  • Sudden cardiac death [ Time Frame: During all observational period (60 months). ]
    Sudden cardiac death associated with fatal arrhythmias.
  • Surgical therapy of heart failure or arrhythmias [ Time Frame: During all observational period (60 months). ]
    Surgical therapy of heart failure or arrhythmias.
  • Cardiovascular death [ Time Frame: During all observational period (60 months). ]
    Death of patient associated with cardiovascular disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood, plasma.
Sampling Method Probability Sample
Study Population Male and female more than 18 years old with verified cancer or with non-toxic dilated cardiomyopathy (control group).
Condition
  • Cardiotoxicity
  • Heart Failure
  • Dilated Cardiomyopathy
Intervention
  • Diagnostic Test: Echocardiography with speckle tracking analysis.
    Transthoracic echocardiography with speckle tracking analysis.
  • Diagnostic Test: 48-hour ECG monitoring.
    Ambulatory 48-hour electrocardiography monitoring.
  • Diagnostic Test: Blood samples analysis.
    Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
Study Groups/Cohorts
  • 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.
    Interventions:
    • Diagnostic Test: Echocardiography with speckle tracking analysis.
    • Diagnostic Test: 48-hour ECG monitoring.
    • Diagnostic Test: Blood samples analysis.
  • 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.
    Interventions:
    • Diagnostic Test: Echocardiography with speckle tracking analysis.
    • Diagnostic Test: 48-hour ECG monitoring.
    • Diagnostic Test: Blood samples analysis.
  • 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.
    Interventions:
    • Diagnostic Test: Echocardiography with speckle tracking analysis.
    • Diagnostic Test: 48-hour ECG monitoring.
    • Diagnostic Test: Blood samples analysis.
  • 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:
    • Diagnostic Test: Echocardiography with speckle tracking analysis.
    • Diagnostic Test: 48-hour ECG monitoring.
    • Diagnostic Test: Blood samples analysis.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 12, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2024
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Elena Y Shupenina, PhD +79161906122 eshupenina@mail.ru
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04055636
Other Study ID Numbers PR_01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Moscow State University of Medicine and Dentistry
Study Sponsor Moscow State University of Medicine and Dentistry
Collaborators Not Provided
Investigators
Principal Investigator: Yury A Vasyuk, MD Moscow State University of Medicine and Dentistry
PRS Account Moscow State University of Medicine and Dentistry
Verification Date August 2019