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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

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.

Condition or disease Intervention/treatment
Cardiotoxicity Heart Failure Dilated Cardiomyopathy Diagnostic Test: Echocardiography with speckle tracking analysis. Diagnostic Test: 48-hour ECG monitoring. Diagnostic Test: Blood samples analysis.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2024


Group/Cohort Intervention/treatment
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.
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.

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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: During all observational period (60 months) ]
    Death of patient from all causes.

  2. Heart transplantation [ Time Frame: During all observational period (60 months). ]
    Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.

  3. Cardioverter-defibrillator implantation [ Time Frame: During all observational period (60 months). ]
    Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.

  4. Hospitalization with heart failure decompensation [ Time Frame: During all observational period (60 months) ]
    Hospitalization of patient due to decompensation of heart failure.


Secondary Outcome Measures :
  1. Thromboembolism. [ Time Frame: During all observational period (60 months). ]
    Venous thromboembolism associated with cancer disease.

  2. Myocardial infarction [ Time Frame: During all observational period (60 months). ]
    Fatal/nonfatal myocardial infarction.

  3. Stroke [ Time Frame: During all observational period (60 months). ]
    Stroke

  4. Sudden cardiac death [ Time Frame: During all observational period (60 months). ]
    Sudden cardiac death associated with fatal arrhythmias.

  5. Surgical therapy of heart failure or arrhythmias [ Time Frame: During all observational period (60 months). ]
    Surgical therapy of heart failure or arrhythmias.

  6. Cardiovascular death [ Time Frame: During all observational period (60 months). ]
    Death of patient associated with cardiovascular disease.


Biospecimen Retention:   Samples Without DNA
Whole blood, plasma.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055636


Contacts
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Contact: Elena Y Shupenina, PhD +79161906122 eshupenina@mail.ru

Locations
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Russian Federation
Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1 Recruiting
Moscow, Moscow Region, Russian Federation, 107095
Contact: Elena Shupenina, PhD    +79161906122    eshupenina@mail.ru   
Sponsors and Collaborators
Moscow State University of Medicine and Dentistry
Investigators
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Principal Investigator: Yury A Vasyuk, MD Moscow State University of Medicine and Dentistry

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Responsible Party: Moscow State University of Medicine and Dentistry
ClinicalTrials.gov Identifier: NCT04055636     History of Changes
Other Study ID Numbers: PR_01
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiotoxicity
Heart Diseases
Cardiomegaly
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries