Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04092309
Other study ID # ACE_SAVA_3Decho_BMT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2019
Est. completion date September 1, 2021

Study information

Verified date April 2020
Source University of Athens
Contact Ignatios Ikonomidis, Assoc.Prof.
Phone +30 2105832192
Email ignoik@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 1, 2021
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ACE inhibitor, Sacubitril-Valsartan
Search for Protective effect after chemotherapy and bone marrow transplantation

Locations

Country Name City State
Greece "Attikon" University General Hospital Athens Attiki

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of treatment in Left Ventricular Function Left Ventricular Function is assessed by calculating Ejection fraction by 3D echocardiography. 2 years
Primary Effect of treatment in left ventricular function Left Ventricular function is assessed by Global Longitudinal Strain by speckle tracking echocardiography 2 years
Primary Effect of treatment in arterial stiffness Arterial Stiffness is evaluated by Pulse Wave Velocity 2 years
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT00766883 - Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant Phase 2
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Completed NCT02564458 - Fitness in Allogeneic Stem Cell Transplantation N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Not yet recruiting NCT01714557 - Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation N/A
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Completed NCT00000603 - Cord Blood Stem Cell Transplantation Study (COBLT) Phase 2
Completed NCT02663622 - Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) Phase 2
Recruiting NCT04937634 - Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT04203108 - ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis Phase 4
Withdrawn NCT03279133 - Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. Phase 4
Completed NCT03654599 - Effects of Digital Stories Intervention on Psychosocial Well-being N/A
Completed NCT05151406 - Myths and Misconceptions About HSCT in a Limited Resource Region N/A
Completed NCT02241005 - Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci N/A
Recruiting NCT03689465 - PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis Phase 4
Recruiting NCT04868786 - Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT03010579 - Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation Phase 4
Active, not recruiting NCT00959140 - Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors N/A