Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease

NCT ID: NCT00427284

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-31

Brief Summary

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The aim of the present study is to investigate wether endothelial dysfunction associated with stable coronary artery disease is altered by selective aldosterone antagonism with Eplerenone as potential anti-inflammatory drug versus placebo.

Additionally we hypothesize that selective aldosterone antagonism reduces systemic inflammatory response such as C-reactive proteine, oxidative stress and pro-inflammatory cytokines.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male patients (\> 30 years of age) with history of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
* Stable cardiovascular medication for at least 4 months Evaluation of the patients will take place at the Department of Internal Medicine, Cardiology, University Hospital Zurich.

Exclusion Criteria

* Evidence for myocardial infarction, unstable angina, stroke within 3 months prior to study entry
* coronary intervention/re-vascularisation procedure within 3 months prior to study entry
* long acting nitrates
* uncontrolled arterial hypertension, defined as RR\>160/90 mmHg
* congestive heart failure (\> NYHA I)
* Ejection fraction \<50%
* AV-Block\>I˚
* creatinine clearance \<50 mL/min
* insulin-dependent diabetes mellitus
* type 2 diabetes with microalbuminuria
* age \< 30 years
* anemia (Hb\<10 g/dl)
* malignancy chronic infection
* smoking
* serum potassium \>5.5 meq/L
* drug abuse
* potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene)
* concomitant use of strong inhibitors of CYP450 3A4 (e.g., ketoconazole, itraconazole)
* known history of Cushing disease or Morbus Addisons or diseases of the thyroid gland
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Ruschitzka, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Cardiology

Locations

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University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK 1033

Identifier Type: -

Identifier Source: org_study_id