Coronary Artery DiseaseNCT00427284
Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease
An observational study of Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2004to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary heart disease
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091
About this study
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.
- Conditions
- Coronary Artery Disease
- Keywords
- Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Ruschitzka, Prof MD, Principal investigator, University Hospital Zurich, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427284
- Sponsor's protocol ID
- EK 1033
- Status last verified
- Dec 2011
- First submitted
- 25 Jan 2007
- Last updated
- 23 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00427284
- Acronym / sponsor ID
- EK 1033
- Conditions
- Coronary Artery Disease
- Keywords
- Eplerenone auf die Endothelfunktion bei Patienten mit stabiler koronarer Herzkrankheit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2004
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary heart disease
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Ruschitzka, Prof MD principal investigator
University Hospital Zurich, Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2011.