CardiotoxicityNCT05508087
Cardiovascular Diagnostic in Assessment of Risk HDS and HCT in Patients With Haemoblasts.
A study testing electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan in people with Cardiotoxicity, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity
- What is being tested?
- electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 17 Jul 2019to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject being over 18 yers of age
- Subject expected for high dose chemotherapy and hematopoietic cell transplantation
Who cannot join
- Subject's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiotoxicity
- Being tested
- electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan
- Keywords
- cardiotoxicity, cardiooncology, oncohematology
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Cardiac death after hematopoietic cell transplantation
Measured: Up to 5 years or in the moment of hematopoietic cell transplantation
Death
Death after hematopoietic cell transplantation
Measured: Up to 5 years or in the moment of hematopoietic cell transplantation
Secondary outcomes (1)
All cardiovascular complications
Cardiovascular complications after hematopoietic cell transplantation
Measured: Up to 5 years or in the moment of hematopoietic cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start17 Jul 2019
- Primary completion1 Mar 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadezhda A. Potemkina, Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508087
- Sponsor's protocol ID
- 2409
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2022
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the Local Ethics Committee's rules, we are not allowed to provide this data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Diagnostic in Assessment of Risk High Dose Chemotherapy and Hematopoietic Cell Transplantation in Patients With Haemoblasts.
- ClinicalTrials.gov ID
- NCT05508087
- Acronym / sponsor ID
- 2409
- Conditions
- Cardiotoxicity
- Keywords
- cardiotoxicity, cardiooncology, oncohematology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- to evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies
| Arm | Type | Receives |
|---|---|---|
| Formerly Arm Label | Other | Diagnostic Test: electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscanto evaluate the possibility of cardiovascular studies in predicting the risk of complications after autologous hematopoietic stem cell transplantation in patients with hematological malignancies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject being over 18 yers of age
- Subject expected for high dose chemotherapy and hematopoietic cell transplantation
Key exclusion criteria (1 listed)
- Subject's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by AngioscanWe 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. | Diagnostic test | Formerly Arm Label |
Primary outcome
Cardiac death
Time frame: Up to 5 years or in the moment of hematopoietic cell transplantation
Cardiac death after hematopoietic cell transplantation
Death
Time frame: Up to 5 years or in the moment of hematopoietic cell transplantation
Death after hematopoietic cell transplantation
1 secondary outcome
All cardiovascular complications
Time frame: Up to 5 years or in the moment of hematopoietic cell transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No. According to the Local Ethics Committee's rules, we are not allowed to provide this data.
Related trials for Cardiotoxicity
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 3
Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot Study
Aluminum Phosphide Poisoning
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadezhda A. Potemkina principal investigator
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan in people with Cardiotoxicity, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death (time frame: Up to 5 years or in the moment of hematopoietic cell transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.