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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00427284
First received: January 25, 2007
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  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 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by University of Zurich:

Enrollment: 42
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with coronary heart disease

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

Locations
Switzerland
University Hospital Zurich, Division of Cardiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Frank Ruschitzka, Prof MD University Hospital Zurich, Division of Cardiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00427284     History of Changes
Other Study ID Numbers: EK 1033
Study First Received: January 25, 2007
Last Updated: December 22, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013