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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092309
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Cardiotoxicity Drug: ACE inhibitor, Sacubitril-Valsartan Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
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.
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arm Intervention/treatment
ACE group
patients after bone marrow transplantation will be treated with ACE inhibitor
Drug: ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Other Name: Sacubitril-Valsartan

Sacubitril Valsartan group
patients after bone marrow transplantation will be treated with sacubitril valsartan
Drug: ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Other Name: Sacubitril-Valsartan

Control group
patients after bone marrow transplantation will be treated neither with ACE i nor with sacubitril valsartan
Drug: ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation
Other Name: Sacubitril-Valsartan




Primary Outcome Measures :
  1. Effect of treatment in Left Ventricular Function [ Time Frame: 2 years ]
    Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography.

  2. Effect of treatment in left ventricular function [ Time Frame: 2 years ]
    Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography

  3. Effect of treatment in arterial stiffness [ Time Frame: 2 years ]
    Arterial Stiffness is evaluated by Pulse Wave Velocity

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092309


Contacts
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Contact: Ignatios Ikonomidis, Assoc.Prof. +30 2105832192 ignoik@gmail.com
Contact: Konstantinos Katogiannis, Fellow +30 2105832192 kenndj89@gmail.com

Locations
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Greece
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, Assoc. Prof Athens University

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Responsible Party: Ignatios Ikonomidis, Principal Investigator, University of Athens
ClinicalTrials.gov Identifier: NCT04092309    
Other Study ID Numbers: ACE_SAVA_3Decho_BMT
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
Cardio-oncology
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Valsartan
LCZ 696
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors