NCT00427284

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

First QC Date

January 25, 2007

Last Update Submit

December 22, 2011

Conditions

Coronary Artery Disease

Keywords

Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coronary heart disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Frank Ruschitzka, Prof MD

    University Hospital Zurich, Division of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

July 1, 2004

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

CH(1)