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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00427284
Other study ID # EK 1033
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received January 25, 2007
Last updated December 22, 2011
Start date July 2004

Study information

Verified date December 2011
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Switzerland University Hospital Zurich, Division of Cardiology Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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