Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease
Information source: University of Zurich
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Phase: Phase 2/Phase 3
Status: Suspended
Sponsored by: University of Zurich Official(s) and/or principal investigator(s):
Frank Ruschitzka MD, Principal Investigator, Affiliation: University Hospital
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.
Clinical Details
Study design: Longitudinal, Defined Population, Prospective Study
Eligibility
Minimum age: 30 Years.
Maximum age: 80 Years.
Gender(s): 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
Locations and Contacts
Additional Information
Starting date: July 2004
Last updated: January 30, 2007
|
