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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2004
First posted: Jan 29, 2007
Registry last updated: Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed