Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

Heart Failure Clinical Trial

— PROMETEY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055636
• Other study ID #: PR_01
• Status: Recruiting
• Start date: June 14, 2019
• Est. completion date: June 2024

Study information

• Verified date: September 2021
• Source: Moscow State University of Medicine and Dentistry
• Contact: Elena Y Shupenina, PhD
• Phone: +79161906122
• Email: eshupenina[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2024
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiotoxicity
• Dilated Cardiomyopathy
• Heart Failure

Intervention

Diagnostic Test:
• Echocardiography with speckle tracking analysis.
Transthoracic echocardiography with speckle tracking analysis.
• 48-hour ECG monitoring.
Ambulatory 48-hour electrocardiography monitoring.
• Blood samples analysis.
Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.

Locations

Country	Name	City	State
Russian Federation	Moscow State University of Medicine and Dentistry, Department of Hospital Therapy ?1	Moscow	Moscow Region

Sponsors (1)

Lead Sponsor	Collaborator
Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Death of patient from all causes.	During all observational period (60 months)
Primary	Heart transplantation	Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.	During all observational period (60 months).
Primary	Cardioverter-defibrillator implantation	Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.	During all observational period (60 months).
Primary	Hospitalization with heart failure decompensation	Hospitalization of patient due to decompensation of heart failure.	During all observational period (60 months)
Secondary	Thromboembolism.	Venous thromboembolism associated with cancer disease.	During all observational period (60 months).
Secondary	Myocardial infarction	Fatal/nonfatal myocardial infarction.	During all observational period (60 months).
Secondary	Stroke	Stroke	During all observational period (60 months).
Secondary	Sudden cardiac death	Sudden cardiac death associated with fatal arrhythmias.	During all observational period (60 months).
Secondary	Surgical therapy of heart failure or arrhythmias	Surgical therapy of heart failure or arrhythmias.	During all observational period (60 months).
Secondary	Cardiovascular death	Death of patient associated with cardiovascular disease.	During all observational period (60 months).