Cardiovascular Diagnostic in Assessment of Risk HDS and HCT in Patients With Haemoblasts.

Cardiotoxicity Clinical Trial

Official title:

Cardiovascular Diagnostic in Assessment of Risk High Dose Chemotherapy and Hematopoietic Cell Transplantation in Patients With Haemoblasts.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508087
• Other study ID #: 2409
• Status: Recruiting
• Start date: July 17, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Maria G. Poltavskaya, PhD
• Phone: +7 (916) 617-84-30
• Email: m.poltavskaya[@]yandex.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject being over 18 yers of age

• Subject expected for high dose chemotherapy and hematopoietic cell transplantation

Exclusion Criteria:

• Subject's refusal

Related Conditions & MeSH terms

• Cardiotoxicity

Intervention

Diagnostic Test:
• electrocardiography, 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.

Locations

Country	Name	City	State
Russian Federation	Sechenov University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change ejection fraction by 10% of the original	Change ejection fraction by 10% of the original after hematopoietic cell transplantation	Through study completion, an average of 5 years after hematopoietic cell transplantation
Other	Change GLS by 12% of the original	Change GLS by 12% of the original after hematopoietic cell transplantation	Through study completion, an average of 5 years after hematopoietic cell transplantation
Other	Development of diastolic dysfunction	Development of diastolic dysfunction after hematopoietic cell transplantation	Through study completion, an average of 5 years after hematopoietic cell transplantation
Other	Change anaerobic threshold<9,5 ml/kg/min	Change anaerobic threshold<9,5 ml/kg/min before and after hematopoietic cell transplantation	Through study completion, an average of 5 years after hematopoietic cell transplantation
Other	Change NTproBNP >125 mmol/l	Change NTproBNP >125 mmol/l before and after hematopoietic cell transplantation	Before and through study completion, an average of 5 years after hematopoietic cell transplantation
Other	Change Troponin T>14 pg/ml	Change Troponin T>14 pg/ml before and after hematopoietic cell transplantation	Before and through study completion, an average of 5 years after hematopoietic cell transplantation
Other	Change GLS <18%	Change GLS <18% before hematopoietic cell transplantation	Before hematopoietic cell transplantation
Other	Change ejection fraction <52%	Change ejection fraction <52% before hematopoietic cell transplantation	Before hematopoietic cell transplantation
Primary	Cardiac death	Cardiac death after hematopoietic cell transplantation	Up to 5 years or in the moment of hematopoietic cell transplantation
Primary	Death	Death after hematopoietic cell transplantation	Up to 5 years or in the moment of hematopoietic cell transplantation
Secondary	All cardiovascular complications	Cardiovascular complications after hematopoietic cell transplantation	Up to 5 years or in the moment of hematopoietic cell transplantation