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

September 26, 2023 updated by: I.M. Sechenov First Moscow State Medical University

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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: Up to 5 years or in the moment of hematopoietic cell transplantation
Cardiac death after hematopoietic cell transplantation
Up to 5 years or in the moment of hematopoietic cell transplantation
Death
Time Frame: Up to 5 years or in the moment of hematopoietic cell transplantation
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
Time Frame: Up to 5 years or in the moment of hematopoietic cell transplantation
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
Time Frame: Through study completion, an average of 5 years after hematopoietic cell transplantation
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
Time Frame: Through study completion, an average of 5 years after hematopoietic cell transplantation
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
Time Frame: Through study completion, an average of 5 years after hematopoietic cell transplantation
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
Time Frame: 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
Through study completion, an average of 5 years after hematopoietic cell transplantation
Change NTproBNP >125 mmol/l
Time Frame: 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
Before and through study completion, an average of 5 years after hematopoietic cell transplantation
Change Troponin T>14 pg/ml
Time Frame: 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
Before and through study completion, an average of 5 years after hematopoietic cell transplantation
Change GLS <18%
Time Frame: Before hematopoietic cell transplantation
Change GLS <18% before hematopoietic cell transplantation
Before hematopoietic cell transplantation
Change ejection fraction <52%
Time Frame: Before hematopoietic cell transplantation
Change ejection fraction <52% before hematopoietic cell transplantation
Before hematopoietic cell transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Nadezhda A. Potemkina, Sechenov University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

December 1, 2024

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)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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