Cardiotoxicity
Conditions
Keywords
cardiotoxicity, cardiooncology, oncohematology
Brief summary
In this research we investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.
Detailed description
Cancer and cardiovascular (CV) disease are the most prevalent diseases in the developed world. Evidence increasingly shows that these conditions are interlinked through common risk factors, coincident in an ageing population, and are connected biologically through some deleterious effects of anticancer treatment on CV health. Anticancer therapies can cause a wide spectrum of short- and long-term cardiotoxic effects such as heart failure, arrhythmias, systolic and diastolic dysfunction, valvular disease, pericarditis, myocarditis, ischemic heart disease, cardiomyopathy, stroke, hypertension. A number of studies have shown that autologous and allogeneic hematopoietic cell transplantation (HCT) contribute to an increased incidence of cardiovascular disease (CVD) and worsening of cardiovascular risk factors (CVRFs) that could contribute to further CVD over time. These observations combined with a notable increase in the number of survivors after HCT in recent years highlight the need for studies aimed at modifying risk or preventing these outcomes by changing specific approaches and/or post-HCT interventions. The aim of this study is to evaluate the prognostic value of cardiological diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts. This is an observational, prospective single- centre, non-randomized study. In this research included patients with haemoblasts. Before and after hematological treatment, all patients undergo a cardiological examination, including examination, history taking, measurement of blood pressure, as well as instrumental examination, including ECG, echocardiography with the determination of global longitudinal deformation, cardiopulmonary pulmonary test, assessment of endothelial function by Angioscan. In addition, all subjects take blood for troponin T and NT-proBNP. Patients were followed-up from 3 to 12 month after hematopoietic cell transplantation. In this study was included patients with confirmed hemoblastosis. Written informed consent was obtained from all subjects. Inclusion criteria were being over 18 yers of age and expected for high dose chemotherapy and hematopoietic cell transplantation, Exclusion criteria were patient's refusal.
Interventions
DIAGNOSTIC_TESTelectrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan
We use electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after high dose chemotherapy and hematopoietic cell transplantation in patients with haemoblasts.
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies
Intervention model description
to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject being over 18 yers of age * Subject expected for high dose chemotherapy and hematopoietic cell transplantation
Exclusion criteria
* Subject's refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | Up to 5 years or in the moment of hematopoietic cell transplantation | Cardiac death after hematopoietic cell transplantation |
| Death | Up to 5 years or in the moment of hematopoietic cell transplantation | Death after hematopoietic cell transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cardiovascular complications | Up to 5 years or in the moment of hematopoietic cell transplantation | Cardiovascular complications after hematopoietic cell transplantation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change anaerobic threshold<9,5 ml/kg/min | Through study completion, an average of 5 years after hematopoietic cell transplantation | Change anaerobic threshold\<9,5 ml/kg/min before and after hematopoietic cell transplantation |
| Change NTproBNP >125 mmol/l | Before and through study completion, an average of 5 years after hematopoietic cell transplantation | Change NTproBNP \>125 mmol/l before and after hematopoietic cell transplantation |
| Development of diastolic dysfunction | Through study completion, an average of 5 years after hematopoietic cell transplantation | Development of diastolic dysfunction after hematopoietic cell transplantation |
| Change GLS <18% | Before hematopoietic cell transplantation | Change GLS \<18% before hematopoietic cell transplantation |
| Change ejection fraction <52% | Before hematopoietic cell transplantation | Change ejection fraction \<52% before hematopoietic cell transplantation |
| Change Troponin T>14 pg/ml | Before and through study completion, an average of 5 years after hematopoietic cell transplantation | Change Troponin T\>14 pg/ml before and after hematopoietic cell transplantation |
| Change ejection fraction by 10% of the original | Through study completion, an average of 5 years after hematopoietic cell transplantation | Change ejection fraction by 10% of the original after hematopoietic cell transplantation |
| Change GLS by 12% of the original | Through study completion, an average of 5 years after hematopoietic cell transplantation | Change GLS by 12% of the original after hematopoietic cell transplantation |
Countries
Russia
Outcome results
None listed