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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427284
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : December 23, 2011
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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.

Condition or disease
Coronary Artery Disease

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : July 2004

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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with coronary heart disease

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427284

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University Hospital Zurich, Division of Cardiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Frank Ruschitzka, Prof MD University Hospital Zurich, Division of Cardiology
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Responsible Party: University of Zurich Identifier: NCT00427284    
Other Study ID Numbers: EK 1033
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011
Keywords provided by University of Zurich:
Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases