Clinical trial NCT04055636: Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.
Official title: Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Heart Failure
Dilated Cardiomyopathy
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: All-cause mortality
timeFrame: During all observational period (60 months)
measure: Heart transplantation
timeFrame: During all observational period (60 months).
measure: Cardioverter-defibrillator implantation
timeFrame: During all observational period (60 months).
measure: Hospitalization with heart failure decompensation
timeFrame: During all observational period (60 months)
Secondary outcomes:
measure: Thromboembolism.
timeFrame: During all observational period (60 months).
measure: Myocardial infarction
timeFrame: During all observational period (60 months).
measure: Stroke
timeFrame: During all observational period (60 months).
measure: Sudden cardiac death
timeFrame: During all observational period (60 months).
measure: Surgical therapy of heart failure or arrhythmias
timeFrame: During all observational period (60 months).
measure: Cardiovascular death
timeFrame: During all observational period (60 months).
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1
state: Moscow Region
Study officials:
affiliation: Moscow State University of Medicine and Dentistry
name: Yury A Vasyuk, MD
role: PRINCIPAL_INVESTIGATOR
References: