Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04055636
Study type	Observational
Source	Moscow State University of Medicine and Dentistry
Contact	Elena Y Shupenina, PhD
Phone	+79161906122
Email	eshupenina@mail.ru
Status	Recruiting
Phase
Start date	June 14, 2019
Completion date	June 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy. — PROMETEY

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms