Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

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.

Conditions

• Cardiotoxicity
• Heart Failure
• Dilated Cardiomyopathy

Interventions

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.

Sponsors & Collaborators

• Moscow State University of Medicine and Dentistry

  lead OTHER

Principal Investigators

• Yury A Vasyuk, MD · Moscow State University of Medicine and Dentistry

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-14

Primary Completion

2022-06-30

Completion

2024-06-30

Countries

• Russia