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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiotoxicity
• Intervention / Treatment: Diagnostic test: electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Sechenov University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Subject's refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Formerly Arm Label; to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	Cardiac death after hematopoietic cell transplantation	Up to 5 years or in the moment of hematopoietic cell transplantation
Death	Death after hematopoietic cell transplantation	Up to 5 years or in the moment of hematopoietic cell transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cardiovascular complications	Cardiovascular complications after hematopoietic cell transplantation	Up to 5 years or in the moment of hematopoietic cell transplantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Development of diastolic dysfunction	Development of diastolic dysfunction after hematopoietic cell transplantation	Through study completion, an average of 5 years after hematopoietic cell transplantation
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
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
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
Change GLS <18%	Change GLS <18% before hematopoietic cell transplantation	Before hematopoietic cell transplantation
Change ejection fraction <52%	Change ejection fraction <52% before hematopoietic cell transplantation	Before hematopoietic cell transplantation

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Nadezhda A. Potemkina, Sechenov University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cardiotoxicity, cardiooncology, oncohematology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Heart Diseases; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: 2409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the Local Ethics Committee's rules, we are not allowed to provide this data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No