Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease - Full Text View

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

This study has been suspended.

Sponsors and Collaborators:	University of Zurich University Hospital
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00427284

Purpose

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	Phase
Coronary Artery Disease	Phase II Phase III

MedlinePlus related topics:

Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study

Further study details as provided by University of Zurich:

Study Start Date:

July 2004

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427284

Sponsors and Collaborators

University of Zurich

University Hospital

Investigators


Principal Investigator:	Frank Ruschitzka MD	University Hospital

More Information

Study ID Numbers:	EK 1033
First Received:	January 25, 2007
Last Updated:	January 30, 2007
ClinicalTrials.gov Identifier:	NCT00427284
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit

Study placed in the following topic categories:

Arterial Occlusive Diseases

Coronary Disease

Eplerenone

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008