Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

• Conditions: Heart Failure; Cardiotoxicity; Dilated Cardiomyopathy

• Registration Number: NCT04055636
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-14
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18
• Primary Completion: 2022-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1; 🇷🇺 Moscow, Moscow Region, Russian Federation