NCT05508087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

5.6 years

First QC Date

August 15, 2022

Last Update Submit

July 10, 2025

Conditions

Cardiotoxicity

Keywords

cardiotoxicity, cardiooncology, oncohematology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • All cardiovascular complications

    Up to 5 years or in the moment of hematopoietic cell transplantation

Other Outcomes (8)

  • Change ejection fraction by 10% of the original

    Through study completion, an average of 5 years after hematopoietic cell transplantation

  • Change GLS by 12% of the original

    Through study completion, an average of 5 years after hematopoietic cell transplantation

  • Development of diastolic dysfunction

    Through study completion, an average of 5 years after hematopoietic cell transplantation

  • +5 more other outcomes

Study Arms (1)

Formerly Arm Label

OTHER

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

Interventions

electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by AngioscanDIAGNOSTIC_TEST

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.

Formerly Arm Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subject's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sechenov University

Moscow, Russia

Location

MeSH Terms

Conditions

Cardiotoxicity

Interventions

ElectrocardiographyEchocardiographyExercise Test

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Nadezhda A. Potemkina

    Sechenov University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 19, 2022

Study Start

July 17, 2019

Primary Completion

March 1, 2025

Study Completion

July 10, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

According to the Local Ethics Committee's rules, we are not allowed to provide this data.

Locations

RU(1)