CardiotoxicityPROMETEYNCT04055636
Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.
An observational study of Cardiotoxicity and Heart Failure, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiotoxicity, Heart Failure, Dilated Cardiomyopathy
- What is being tested?
- Echocardiography with speckle tracking analysis., 48-hour ECG monitoring. and Blood samples analysis.
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 14 Jun 2019to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female more than 18 years old with verified cancer or with non-toxic dilated cardiomyopathy (control group).
Who may be able to join
- 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.
Who cannot join
- refusal of patient,
- sepsis,
- coma, delirium,
- mental disorders,
- left chest radiation therapy,
- metastases in central nervous system.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1
Moscow, Moscow Oblast, 107095
Elena Shupenina, PhD, +79161906122, eshupenina@mail.ru
About this study
Official title: Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
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.
Read more
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
- Being tested
- Echocardiography with speckle tracking analysis., 48-hour ECG monitoring., Blood samples analysis.
- Medical subject headings
- Cardiotoxicity, Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography with speckle tracking analysis.Diagnostic test
Transthoracic echocardiography with speckle tracking analysis.
48-hour ECG monitoring.Diagnostic test
Ambulatory 48-hour electrocardiography monitoring.
Blood samples analysis.Diagnostic test
Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| cancer survivors with heart failure and/or fatal arrhythmias | Patients undergoing cancer therapy for the last 3-4 years with signs of heart failure and/or life-threatening arrhythmias. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. Receives: Diagnostic Test: Echocardiography with speckle tracking analysis.; Diagnostic Test: 48-hour ECG monitoring.; Diagnostic Test: Blood samples analysis. | |
| Cancer survivors without complications | Patients undergoing cancer therapy for the last 3-4 years without signs of heart failure and/or life-threatening arrhythmias. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. Receives: Diagnostic Test: Echocardiography with speckle tracking analysis.; Diagnostic Test: 48-hour ECG monitoring.; Diagnostic Test: Blood samples analysis. | |
| Cancer patients before chemotherapy | Cancer patients before administered chemotherapy. Interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. Receives: Diagnostic Test: Echocardiography with speckle tracking analysis.; Diagnostic Test: 48-hour ECG monitoring.; Diagnostic Test: Blood samples analysis. | |
| Patients with non-toxic dilated cardiomyopathy (control). | Patients with non-toxic dilated cardiomyopathy. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. Receives: Diagnostic Test: Echocardiography with speckle tracking analysis.; Diagnostic Test: 48-hour ECG monitoring.; Diagnostic Test: Blood samples analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death of patient from all causes.
Measured: During all observational period (60 months)
Heart transplantation
Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
Measured: During all observational period (60 months).
Cardioverter-defibrillator implantation
Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
Measured: During all observational period (60 months).
Hospitalization with heart failure decompensation
Hospitalization of patient due to decompensation of heart failure.
Measured: During all observational period (60 months)
Secondary outcomes (6)
Thromboembolism.
Venous thromboembolism associated with cancer disease.
Measured: During all observational period (60 months).
Myocardial infarction
Fatal/nonfatal myocardial infarction.
Measured: During all observational period (60 months).
Stroke
Stroke
Measured: During all observational period (60 months).
Sudden cardiac death
Sudden cardiac death associated with fatal arrhythmias.
Measured: During all observational period (60 months).
Surgical therapy of heart failure or arrhythmias
Surgical therapy of heart failure or arrhythmias.
Measured: During all observational period (60 months).
Cardiovascular death
Death of patient associated with cardiovascular disease.
Measured: During all observational period (60 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start14 Jun 2019
- Primary completionJun 2022 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow State University of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yury A Vasyuk, MD, Principal investigator, Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055636
- Sponsor's protocol ID
- PR_01
- Acronym
- PROMETEY
- Status last verified
- Sep 2021
- First submitted
- 12 Aug 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
- ClinicalTrials.gov ID
- NCT04055636
- Acronym / sponsor ID
- PROMETEY / PR_01
- Conditions
- Cardiotoxicity, Heart Failure, Dilated Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Moscow State University of Medicine and DentistryUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cancer survivors with heart failure and/or fatal arrhythmias | – | Diagnostic Test: Echocardiography with speckle tracking analysis., Diagnostic Test: 48-hour ECG monitoring., Diagnostic Test: Blood samples analysis.Patients undergoing cancer therapy for the last 3-4 years with signs of heart failure and/or life-threatening arrhythmias. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. |
| Cancer survivors without complications | – | Diagnostic Test: Echocardiography with speckle tracking analysis., Diagnostic Test: 48-hour ECG monitoring., Diagnostic Test: Blood samples analysis.Patients undergoing cancer therapy for the last 3-4 years without signs of heart failure and/or life-threatening arrhythmias. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. |
| Cancer patients before chemotherapy | – | Diagnostic Test: Echocardiography with speckle tracking analysis., Diagnostic Test: 48-hour ECG monitoring., Diagnostic Test: Blood samples analysis.Cancer patients before administered chemotherapy. Interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. |
| Patients with non-toxic dilated cardiomyopathy (control). | – | Diagnostic Test: Echocardiography with speckle tracking analysis., Diagnostic Test: 48-hour ECG monitoring., Diagnostic Test: Blood samples analysis.Patients with non-toxic dilated cardiomyopathy. Administered interventions: physical examination, echocardiography with speckle tracking analysis, 48-hour ECG monitoring, blood samples analysis for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female more than 18 years old with verified cancer or with non-toxic dilated cardiomyopathy (control group).
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- refusal of patient,
- sepsis,
- coma, delirium,
- mental disorders,
- left chest radiation therapy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography with speckle tracking analysis.Transthoracic echocardiography with speckle tracking analysis. | Diagnostic test | Cancer patients before chemotherapy, Cancer survivors without complications, Patients with non-toxic dilated cardiomyopathy (control)., cancer survivors with heart failure and/or fatal arrhythmias |
| 48-hour ECG monitoring.Ambulatory 48-hour electrocardiography monitoring. | Diagnostic test | Cancer patients before chemotherapy, Cancer survivors without complications, Patients with non-toxic dilated cardiomyopathy (control)., cancer survivors with heart failure and/or fatal arrhythmias |
| Blood samples analysis.Analysis of blood samples for biochemistry, biomarkers of myocardial damage, fibrosis and inflammation. | Diagnostic test | Cancer patients before chemotherapy, Cancer survivors without complications, Patients with non-toxic dilated cardiomyopathy (control)., cancer survivors with heart failure and/or fatal arrhythmias |
Primary outcome
All-cause mortality
Time frame: During all observational period (60 months)
Death of patient from all causes.
Heart transplantation
Time frame: During all observational period (60 months).
Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
Cardioverter-defibrillator implantation
Time frame: During all observational period (60 months).
Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
Hospitalization with heart failure decompensation
Time frame: During all observational period (60 months)
Hospitalization of patient due to decompensation of heart failure.
6 secondary outcomes
Thromboembolism.
Time frame: During all observational period (60 months).
Myocardial infarction
Time frame: During all observational period (60 months).
Stroke
Time frame: During all observational period (60 months).
Sudden cardiac death
Time frame: During all observational period (60 months).
Surgical therapy of heart failure or arrhythmias
Time frame: During all observational period (60 months).
Cardiovascular death
Time frame: During all observational period (60 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yury A Vasyuk, MD principal investigator
Moscow State University of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Heart Failure, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Y Shupenina, PhD (+79161906122, eshupenina@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: During all observational period (60 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.