NCT04092309

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

September 14, 2019

Last Update Submit

April 1, 2020

Conditions

Hematopoietic Stem Cell TransplantationCardiotoxicity

Keywords

Cardio-oncology

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

ACE group

OTHER

patients after bone marrow transplantation will be treated with ACE inhibitor

Drug: ACE inhibitor, Sacubitril-Valsartan

Sacubitril Valsartan group

OTHER

patients after bone marrow transplantation will be treated with sacubitril valsartan

Drug: ACE inhibitor, Sacubitril-Valsartan

Control group

OTHER

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

Drug: ACE inhibitor, Sacubitril-Valsartan

Interventions

ACE inhibitor, Sacubitril-ValsartanDRUG

Search for Protective effect after chemotherapy and bone marrow transplantation

Also known as: Sacubitril-Valsartan
ACE groupControl groupSacubitril Valsartan group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39983618DERIVED

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Angiotensin-Converting Enzyme Inhibitorssacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Ignatios Ikonomidis, Assoc. Prof

    Athens University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, Assoc.Prof.

CONTACT

+30 2105832192ignoik@gmail.com

Konstantinos Katogiannis, Fellow

CONTACT

+30 2105832192kenndj89@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2019

First Posted

September 17, 2019

Study Start

September 20, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)