Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation
NCT ID: NCT04092309
Last Updated: 2020-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-09-20
2021-09-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ACE group
patients after bone marrow transplantation will be treated with ACE inhibitor
ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Sacubitril Valsartan group
patients after bone marrow transplantation will be treated with sacubitril valsartan
ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Control group
patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan
ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Interventions
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ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* that have just been treated with bone marrow transplantation due to haematological malignancies.
Exclusion Criteria
* 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
* Blood Pressure\<90 mmHg
* GFR\<30 ml/min/1,73m2
* Unwilling to recruit
* Uncontrolled Arterial hypertension
18 Years
ALL
No
Sponsors
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University of Athens
OTHER
Responsible Party
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Ignatios Ikonomidis
Principal Investigator
Principal Investigators
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Ignatios Ikonomidis, Assoc. Prof
Role: PRINCIPAL_INVESTIGATOR
Athens University
Locations
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"Attikon" University General Hospital
Athens, Attica, Greece
Countries
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Central Contacts
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References
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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.
Other Identifiers
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ACE_SAVA_3Decho_BMT
Identifier Type: -
Identifier Source: org_study_id
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