Hematopoietic Stem Cell TransplantationNCT04092309
Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation
A study testing ACE inhibitor, Sacubitril-Valsartan in people with Hematopoietic Stem Cell Transplantation and Cardiotoxicity, run by University of Athens at 1 site in Greece.
Trial summary
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Cardiotoxicity
- What is being tested?
- ACE inhibitor, Sacubitril-Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 20 Sep 2019to 1 Sep 2021
- 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
- Adolescents male and female
- that have just been treated with bone marrow transplantation due to haematological malignancies.
Who cannot join
- Coronary Artery Disease
- Permanent Atrial Fibrilation
- Signs of Left Ventricular Hypertrophy on electrocardiography or echocardiography
- Left ventricle Ejection Fraction<50% or segmental wall motion abnormalities of left ventricle
- More than moderate valvular disease
- Primary Myocardiopathy
Show all 10Show fewer
- Blood Pressure<90 mmHg
- GFR<30 ml/min/1,73m2
- Unwilling to recruit
- Uncontrolled Arterial hypertension
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
"Attikon" University General Hospital
Athens, Attica, 12462
Ignatios Ikonomidis, MD
About this study
Official title: Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Left Atrial and Left Ventricular Performance, as Assessed With 3D Echocardiography, in Patients After Bone Marrow Transplantation.
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role.
Read the detailed description
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients in preventing cardiotoxicity when administered immediately after transplantation.
The effect of medication will be studied in detail:
- in global longitudinal strain of left ventricle (GLS), ii) in the volume change of the right and the left ventricle, through the cardiac cycle using 3D echocardiography, iii) in the Myocardial Work Index (MWI) of the left ventricle, with a strain -pressure curve study iv) in the 4D strain of the left atrium, v) in elastic properties of aorta (pulse wave velocity (PWV), central systolic pressure (CSBP-mmHg) and augmentation index (Aix%), vii) in permeability of glycocalyx and viii) in serum biomarker values, namely troponin I high sensitivity and atrial natriuretic peptide (NT-proBNP).
- Being tested
- ACE inhibitor, Sacubitril-Valsartan
- Keywords
- Cardio-oncology
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE inhibitor, Sacubitril-ValsartanDrug
Also called Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
| Study group | Role | What they receive |
|---|---|---|
| ACE group | Other | patients after bone marrow transplantation will be treated with ACE inhibitor Receives: Drug: ACE inhibitor, Sacubitril-Valsartan |
| Sacubitril Valsartan group | Other | patients after bone marrow transplantation will be treated with sacubitril valsartan Receives: Drug: ACE inhibitor, Sacubitril-Valsartan |
| Control group | Other | patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan Receives: Drug: ACE inhibitor, Sacubitril-Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment in Left Ventricular Function
Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.
Measured: 2 years
Effect of treatment in left ventricular function
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Measured: 2 years
Effect of treatment in arterial stiffness
Arterial Stiffness is evaluated by Pulse Wave Velocity
Measured: 2 years
Effect of treatment in glycocalyx thickness
Glycocalyx thickness is assessed by measuring perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 µm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start20 Sep 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group after bone marrow transpalntation treated with ACE one group after bone marrow transpalntation treated with sacubitril-valsartan one group after bone marrow transpalntation treated with none of these (control group)
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Assoc. Prof, Principal investigator, Athens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092309
- Sponsor's protocol ID
- ACE_SAVA_3Decho_BMT
- Status last verified
- Apr 2020
- First submitted
- 14 Sep 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katogiannis K, Ikonomidis I, Farmakis D, Thymis J, Stamouli M, Koliou GA, Makavos G, Tsilivarakis D, Vythoulkas D, Tsirigotis P. Effect of Sacubitril/Valsartan or Enalapril on Left Ventricular Function in Patients With Hematologic Malignancies Treated With Bone Marrow Transplantation: A Randomized Controlled Trial. JACC Adv. 2025 Mar;4(3):101628. doi: 10.1016/j.jacadv.2025.101628. Epub 2025 Feb 20.
PubMed 39983618
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Left Atrial and Left Ventricular Performance, as Assessed With 3D Echocardiography, in Patients After Bone Marrow Transplantation.
- ClinicalTrials.gov ID
- NCT04092309
- Acronym / sponsor ID
- ACE_SAVA_3Decho_BMT
- Keywords
- Cardio-oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 17 Sep 2019 (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.
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients by assessing cardiovascular and endothelial parameters in order to search for a potent protective role.
Detailed description
The purpose of the present study is to investigate the effect of ACE inhibitors and the sacubitril-valsartan complex in bone marrow transplant patients in preventing cardiotoxicity when administered immediately after transplantation.
The effect of medication will be studied in detail:
- in global longitudinal strain of left ventricle (GLS), ii) in the volume change of the right and the left ventricle, through the cardiac cycle using 3D echocardiography, iii) in the Myocardial Work Index (MWI) of the left ventricle, with a strain -pressure curve study iv) in the 4D strain of the left atrium, v) in elastic properties of aorta (pulse wave velocity (PWV), central systolic pressure (CSBP-mmHg) and augmentation index (Aix%), vii) in permeability of glycocalyx and viii) in serum biomarker values, namely troponin I high sensitivity and atrial natriuretic peptide (NT-proBNP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- one group after bone marrow transpalntation treated with ACE one group after bone marrow transpalntation treated with sacubitril-valsartan one group after bone marrow transpalntation treated with none of these (control group)
| Arm | Type | Receives |
|---|---|---|
| ACE group | Other | Drug: ACE inhibitor, Sacubitril-Valsartanpatients after bone marrow transplantation will be treated with ACE inhibitor |
| Sacubitril Valsartan group | Other | Drug: ACE inhibitor, Sacubitril-Valsartanpatients after bone marrow transplantation will be treated with sacubitril valsartan |
| Control group | Other | Drug: ACE inhibitor, Sacubitril-Valsartanpatients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adolescents male and female
- that have just been treated with bone marrow transplantation due to haematological malignancies.
Key exclusion criteria (10 listed)
- Coronary Artery Disease
- Permanent Atrial Fibrilation
- Signs of Left Ventricular Hypertrophy on electrocardiography or echocardiography
- Left ventricle Ejection Fraction<50% or segmental wall motion abnormalities of left ventricle
- More than moderate valvular disease
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 |
|---|---|---|
| ACE inhibitor, Sacubitril-ValsartanAlso: Sacubitril-ValsartanSearch for Protective effect after chemotherapy and bone marrow transplantation | Drug | ACE group, Control group, Sacubitril Valsartan group |
Primary outcome
Effect of treatment in Left Ventricular Function
Time frame: 2 years
Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.
Effect of treatment in left ventricular function
Time frame: 2 years
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Effect of treatment in arterial stiffness
Time frame: 2 years
Arterial Stiffness is evaluated by Pulse Wave Velocity
Effect of treatment in glycocalyx thickness
Time frame: 2 years
Glycocalyx thickness is assessed by measuring perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 µm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 39983618Katogiannis K, Ikonomidis I, Farmakis D, Thymis J, Stamouli M, Koliou GA, Makavos G, Tsilivarakis D, Vythoulkas D, Tsirigotis P. Effect of Sacubitril/Valsartan or Enalapril on Left Ventricular Function in Patients With Hematologic Malignancies Treated With Bone Marrow Transplantation: A Randomized Controlled Trial. JACC Adv. 2025 Mar;4(3):101628. doi: 10.1016/j.jacadv.2025.101628. Epub 2025 Feb 20.
- Individual participant dataSharing planned: No
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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.
Ignatios Ikonomidis, Assoc. Prof principal investigator
Athens 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 ACE inhibitor, Sacubitril-Valsartan in people with Hematopoietic Stem Cell Transplantation and Cardiotoxicity, run by University of Athens at 1 site in Greece.
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 10 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: status not confirmed, as of the sponsor's last update on 3 Apr 2020. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ignatios Ikonomidis, Assoc.Prof. (+30 2105832192, ignoik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of treatment in Left Ventricular Function (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092309, which also lists 1 linked publication.
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 3 Apr 2020.