Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

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 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

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