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The Effect of EPLerenone on Ischemia Reperfusion Injury in Human myoCARDium

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemia-reperfusion Injury

Intervention: Eplerenone (Drug); Aldosterone (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
Niels P. Riksen, Dr, Principal Investigator, Affiliation: Radboud University
Henri A. van Swieten, Prof dr ir, Principal Investigator, Affiliation: Radboud University

Summary

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

Clinical Details

Official title: The Effect of Eplerenone on Ischemia Reperfusion Injury in Human Myocardium (EPLICARD Study)

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

Primary outcome: contractile function after simulated ischemia and reperfusion in response to eplerenone

Secondary outcome: contractile function in response to eplerenone vs eplerenone and caffeine

Detailed description: In animal studies, the mineralocorticoid receptor antagonist eplerenone appears to limit myocardial infarct size. This cardioprotective effect might explain, at least in part, the beneficial effect on mortality of eplerenone in patients with heart failure. Previous animal studies suggest that this cardioprotective effect is mediated by an increased formation of the endogenous nucleoside adenosine. Our objective is to study for the first time in human myocardial tissue ex vivo wether eplerenone limits ischemia reperfusion injury and whether this is mediated by adenosine receptor stimulation. From patients undergoing open heart surgery, the right atrial appendage will be harvested by the cardiothoracic surgeon. In the laboratory, two trabeculae will be dissected and suspended in an organ bath. Contraction will be induced by electrical field stimulation. Recovery of contractile force after a period of simulated ischemia and reperfusion will be used as an endpoint of ischemia-reperfusion injury. The trabeculae of each patient will be randomized to pretreatment with A)ischemic preconditioning (IP) of no IP as a positive control experiment; B)eplerenone or vehicle; C)eplerenone with or without caffeine; and D)aldosterone with and without eplerenone.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age>18 years

- willing to sign informed consent

- planned elective surgery with extracorporal circulation

Exclusion Criteria:

- use of theophylline

- use of sulfonylureas

- use of oral antiarrhythmics (not beta blockers)

- use of dipyridamole, use of mineralocorticoid receptor antagonists

- atrial arrhythmias

- right ventricular failure

- known atrial enlargement

Locations and Contacts

Radboud University Medical Centre, Nijmegen, Gelderland 6500HB, Netherlands; Recruiting
Daniƫlle van den Berg, MSc, Phone: +31 24 361 3691, Email: Danielle.vandenBerg@radboudumc.nl
Niels P. Riksen, Dr., Phone: +31 24 361 3691, Email: niels.riksen@radboudumc.nl
Niels P. Riksen, Dr., Principal Investigator
Daniƫlle van den Berg, MSc, Sub-Investigator
Additional Information

Related publications:

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.

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.

Starting date: March 2014
Last updated: June 23, 2015

Page last updated: August 23, 2015

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