Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation

NCT ID: NCT04092309

Last Updated: 2020-04-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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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 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).

Conditions

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Hematopoietic Stem Cell Transplantation Cardiotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ACE group

patients after bone marrow transplantation will be treated with ACE inhibitor

Group Type OTHER

ACE inhibitor, Sacubitril-Valsartan

Intervention Type DRUG

Search for Protective effect after chemotherapy and bone marrow transplantation

Sacubitril Valsartan group

patients after bone marrow transplantation will be treated with sacubitril valsartan

Group Type OTHER

ACE inhibitor, Sacubitril-Valsartan

Intervention Type DRUG

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

Group Type OTHER

ACE inhibitor, Sacubitril-Valsartan

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Sacubitril-Valsartan

Eligibility Criteria

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Inclusion Criteria

* Adolescents male and female
* that have just been treated with bone marrow transplantation due to haematological malignancies.

Exclusion Criteria

* 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
* Blood Pressure\<90 mmHg
* GFR\<30 ml/min/1,73m2
* Unwilling to recruit
* Uncontrolled Arterial hypertension
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Ignatios Ikonomidis

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Ignatios Ikonomidis, Assoc.Prof.

Role: CONTACT

+30 2105832192

Konstantinos Katogiannis, Fellow

Role: CONTACT

+30 2105832192

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.

Reference Type DERIVED
PMID: 39983618 (View on PubMed)

Other Identifiers

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ACE_SAVA_3Decho_BMT

Identifier Type: -

Identifier Source: org_study_id

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