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

University of Zurich (UZH)

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00427284

EK 1033

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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