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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00427284

Enrollment

Registered

2007-01-29

Start date

2004-07-31

Completion date

Unknown

Last updated

2011-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Countries

Switzerland

Outcome results