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

Primary Purpose

Hematopoietic Stem Cell Transplantation, Cardiotoxicity

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ACE inhibitor, Sacubitril-Valsartan
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematopoietic Stem Cell Transplantation focused on measuring Cardio-oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "Attikon" University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

ACE group

Sacubitril Valsartan group

Control group

Arm Description

patients after bone marrow transplantation will be treated with ACE inhibitor

patients after bone marrow transplantation will be treated with sacubitril valsartan

patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan

Outcomes

Primary Outcome Measures

Effect of treatment in Left Ventricular Function
Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.
Effect of treatment in left ventricular function
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Effect of treatment in arterial stiffness
Arterial Stiffness is evaluated by Pulse Wave Velocity
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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2019
Last Updated
April 1, 2020
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04092309
Brief Title
Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplantation, Cardiotoxicity
Keywords
Cardio-oncology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACE group
Arm Type
Other
Arm Description
patients after bone marrow transplantation will be treated with ACE inhibitor
Arm Title
Sacubitril Valsartan group
Arm Type
Other
Arm Description
patients after bone marrow transplantation will be treated with sacubitril valsartan
Arm Title
Control group
Arm Type
Other
Arm Description
patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan
Intervention Type
Drug
Intervention Name(s)
ACE inhibitor, Sacubitril-Valsartan
Other Intervention Name(s)
Sacubitril-Valsartan
Intervention Description
Search for Protective effect after chemotherapy and bone marrow transplantation
Primary Outcome Measure Information:
Title
Effect of treatment in Left Ventricular Function
Description
Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.
Time Frame
2 years
Title
Effect of treatment in left ventricular function
Description
Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography
Time Frame
2 years
Title
Effect of treatment in arterial stiffness
Description
Arterial Stiffness is evaluated by Pulse Wave Velocity
Time Frame
2 years
Title
Effect of treatment in glycocalyx thickness
Description
Glycocalyx thickness is assessed by measuring perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 µm
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignatios Ikonomidis, Assoc.Prof.
Phone
+30 2105832192
Email
ignoik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Katogiannis, Fellow
Phone
+30 2105832192
Email
kenndj89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignatios Ikonomidis, Assoc. Prof
Organizational Affiliation
Athens University
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Attikon" University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignatios Ikonomidis, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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