Clinical trial NCT05508087: Cardiovascular Diagnostic in Assessment of Risk HDS and HCT in Patients With Haemoblasts.
Official title: Cardiovascular Diagnostic in Assessment of Risk High Dose Chemotherapy and Hematopoietic Cell Transplantation in Patients With Haemoblasts.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiotoxicity
Keywords: cardiotoxicity, cardiooncology, oncohematology
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Subject being over 18 yers of age
* Subject expected for high dose chemotherapy and hematopoietic cell transplantation

Exclusion Criteria:

* Subject's refusal

Primary outcomes:
measure: Cardiac death
timeFrame: Up to 5 years or in the moment of hematopoietic cell transplantation
measure: Death
timeFrame: Up to 5 years or in the moment of hematopoietic cell transplantation
Secondary outcomes:
measure: All cardiovascular complications
timeFrame: Up to 5 years or in the moment of hematopoietic cell transplantation
Other outcomes:
measure: Change ejection fraction by 10% of the original
timeFrame: Through study completion, an average of 5 years after hematopoietic cell transplantation
measure: Change GLS by 12% of the original
timeFrame: Through study completion, an average of 5 years after hematopoietic cell transplantation
measure: Development of diastolic dysfunction
timeFrame: Through study completion, an average of 5 years after hematopoietic cell transplantation
measure: Change anaerobic threshold<9,5 ml/kg/min
timeFrame: Through study completion, an average of 5 years after hematopoietic cell transplantation
measure: Change NTproBNP >125 mmol/l
timeFrame: Before and through study completion, an average of 5 years after hematopoietic cell transplantation
measure: Change Troponin T>14 pg/ml
timeFrame: Before and through study completion, an average of 5 years after hematopoietic cell transplantation
measure: Change GLS <18%
timeFrame: Before hematopoietic cell transplantation
measure: Change ejection fraction <52%
timeFrame: Before hematopoietic cell transplantation
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: Sechenov University
name: Nadezhda A. Potemkina
role: PRINCIPAL_INVESTIGATOR
References: