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

October 15, 2021 updated by: Moscow State University of Medicine and Dentistry

Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
    • Moscow Region
      • Moscow, Moscow Region, Russian Federation, 107095
        • Recruiting
        • Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: During all observational period (60 months)
Death of patient from all causes.
During all observational period (60 months)
Heart transplantation
Time Frame: During all observational period (60 months).
Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
During all observational period (60 months).
Cardioverter-defibrillator implantation
Time Frame: During all observational period (60 months).
Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
During all observational period (60 months).
Hospitalization with heart failure decompensation
Time Frame: During all observational period (60 months)
Hospitalization of patient due to decompensation of heart failure.
During all observational period (60 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolism.
Time Frame: During all observational period (60 months).
Venous thromboembolism associated with cancer disease.
During all observational period (60 months).
Myocardial infarction
Time Frame: During all observational period (60 months).
Fatal/nonfatal myocardial infarction.
During all observational period (60 months).
Stroke
Time Frame: During all observational period (60 months).
Stroke
During all observational period (60 months).
Sudden cardiac death
Time Frame: During all observational period (60 months).
Sudden cardiac death associated with fatal arrhythmias.
During all observational period (60 months).
Surgical therapy of heart failure or arrhythmias
Time Frame: During all observational period (60 months).
Surgical therapy of heart failure or arrhythmias.
During all observational period (60 months).
Cardiovascular death
Time Frame: During all observational period (60 months).
Death of patient associated with cardiovascular disease.
During all observational period (60 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow State University of Medicine and Dentistry

Investigators

  • Principal Investigator: Yury A Vasyuk, MD, Moscow State University of Medicine and Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2019

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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