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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.
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:
i) 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE group | Other | patients after bone marrow transplantation will be treated with ACE inhibitor |
|
| Sacubitril Valsartan group | Other | patients after bone marrow transplantation will be treated with sacubitril valsartan |
|
| Control group | Other | patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE inhibitor, Sacubitril-Valsartan | Drug | Search for Protective effect after chemotherapy and bone marrow transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment in Left Ventricular Function | Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography. | 2 years |
| Effect of treatment in left ventricular function | Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography | 2 years |
| Effect of treatment in arterial stiffness | Arterial Stiffness is evaluated by Pulse Wave Velocity | 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignatios Ikonomidis, Assoc.Prof. | Contact | +30 2105832192 | ignoik@gmail.com | |
| Konstantinos Katogiannis, Fellow | Contact | +30 2105832192 | kenndj89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ignatios Ikonomidis, Assoc. Prof | Athens University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Attikon" University General Hospital | Recruiting | Athens | Attica | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39983618 | Derived | 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. |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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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)
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|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D020164 | Chemical Actions and Uses |