Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02118753
Other study ID # EPLICARD
Secondary ID
Status Completed
Phase N/A
First received March 14, 2014
Last updated January 11, 2016
Start date March 2014
Est. completion date January 2016

Study information

Verified date January 2016
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

In the laboratory, the researchers will investigate whether the drug eplerenone improves contractile function after ischemia and reperfusion in heart tissue.


Description:

Read more »
Read more »

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Eplerenone
eplerenone administered ex vivo (to the organ bath in which human atrial tissue is exposed)

Locations

Country Name City State
Netherlands Radboud University Medical Centre Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Riksen NP, Zhou Z, Oyen WJ, Jaspers R, Ramakers BP, Brouwer RM, Boerman OC, Steinmetz N, Smits P, Rongen GA. Caffeine prevents protection in two human models of ischemic preconditioning. J Am Coll Cardiol. 2006 Aug 15;48(4):700-7. Epub 2006 Jul 24. — View Citation

Speechly-Dick ME, Grover GJ, Yellon DM. Does ischemic preconditioning in the human involve protein kinase C and the ATP-dependent K+ channel? Studies of contractile function after simulated ischemia in an atrial in vitro model. Circ Res. 1995 Nov;77(5):1030-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary contractile function after simulated ischemia and reperfusion in response to eplerenone The recovery of contractile function (% of baseline) in human myocardial tissue after simulated ischemia and reperfusion in 2 trabeculae will be compared: 1 of the trabeculae will be exposed to eplerenone, the other to vehicle.
We will use the experimental set up as described by Speechly-Dick et al. with small modifications to allow simultaneous measurement of 2 trabeculae from 1 patient. The two trabeculae will be dissected and vertically suspended in an organ bath and linked to a force transducer. During electrical field stimulation, we will calculate the developed force (difference between maximal tension during contraction and minimal tension during relaxation), maximal speed of tension development during contraction and maximal speed of tension during relaxation. We will average these parameters for baseline, and during the experiment. Functional recovery will be expressed as a percentage of baseline.
210 minutes No
See also
  Status Clinical Trial Phase
Recruiting NCT05327348 - Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery Phase 3
Completed NCT00184912 - The Effect of Caffeine on Ischemic Preconditioning N/A
Recruiting NCT05585255 - Clinical Significance of DKK2 Protein in Cerebral Ischemia-reperfusion Injury
Completed NCT05598177 - Effect of Dexmedetomidine Preconditioning on Myocardial Ischemia-reperfusion Injury in Patients Undergoing Open Heart Surgery With Cardiopulmonary Bypass Phase 4
Completed NCT04284592 - Remote Ischemic Postconditioning Increases HIF-1α Plasma Levels and Improves Cardiac Markers After Cardiac Surgery N/A
Withdrawn NCT00441714 - Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise N/A
Completed NCT00248040 - Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation Phase 2
Completed NCT01486212 - Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers N/A
Recruiting NCT06097702 - A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants Phase 1
Completed NCT00224406 - Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation Phase 2
Completed NCT01073202 - Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation N/A
Completed NCT05246618 - FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation Phase 1/Phase 2
Completed NCT01739088 - Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery N/A
Completed NCT01040013 - Gut Oxygenation and Laparoscopy Phase 2
Suspended NCT00184847 - Adenosine Receptors Influence Ischemia-Reperfusion Injury N/A
Completed NCT01172171 - The Effect of Melatonin on Ischemia-reperfusion Injury Following Acute Myocardial Infarction Phase 2
Completed NCT00457405 - Does a Seven Day Treatment With Dipyridamole Induce Protection Against Ischemia-Reperfusion Injury? Phase 4
Completed NCT00184821 - Ischemic Injury and Ischemic Preconditioning in Diabetes N/A
Not yet recruiting NCT00691613 - Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model N/A
Completed NCT03818126 - The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement N/A