Endothelin-Receptor Blockade in Coronary Heart Disease
Selective and Non-Selective Endothelin-Receptor Blockade in Coronary Artey Disease
1 other identifier
interventional
26
1 country
1
Brief Summary
Endothelin is a hormon that causes acute and chronic narrowing of heart vessels. The purpose of this study is to assess whether suppression of this activity by using two types of receptor antagonists can reduce this effect and thus improve blood supply of the heart muscle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2003
Typical duration for phase_1
1 active site
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
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 25, 2007
CompletedFirst Posted
Study publicly available on registry
January 26, 2007
CompletedJanuary 26, 2007
January 1, 2007
January 25, 2007
January 25, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
minimal lumen diameter measured directly after infusion of the ET-antagonist(s)
Secondary Outcomes (1)
fractional flow reserve, coronary flow reserve, intramyocardial resistance measured directly after infusion of the ET-antagonist(s)
Interventions
Eligibility Criteria
You may qualify if:
- coronary artey disease
- stable angina pectoris
- male and post-menopausal female patients
- age above 19 years
- able and willing to conform to the requirements of the study
- provided written informed consent
You may not qualify if:
- severe focal coronary stenosis
- visually calcified stenosis
- aorto-ostial lesion location and unprotected left main stenosis
- pre-menopausal female patients
- diabetes mellitus
- unstable angina pectoris and/or acute Q-wave myocardial infarctaion within the past 72 hours
- current vasoactive medication
- previous percutaneous transluminal revascularization at the site of the target lesion
- lesion which has extremely angulated segments \>90%
- vessel with escessive tortuosity of the proximal segment
- severe hypotension
- severely reduced left ventricular function
- severe carotid stenosis
- patients with pace maker
- patients with elevated liver enzymes
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Internal Medicine II, Medical University of Vienna
Vienna, Vienna, A-1090, Austria
Related Publications (1)
Wexberg P, Sperker W, Morgenthaler NG, Heinzl H, Adlbrecht C, Plass C, Glogar HD, Lang IM, Neunteufl T. Inhomogeneous vasomotor effects of moderate selective and non-selective endothelin-receptor blockade in stable coronary artery disease. Heart. 2009 Aug;95(15):1258-64. doi: 10.1136/hrt.2008.158550. Epub 2009 May 3.
PMID: 19414437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Neunteufl, MD
Dept. of Internal Medicine II, Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 25, 2007
First Posted
January 26, 2007
Study Start
May 1, 2003
Study Completion
August 1, 2006
Last Updated
January 26, 2007
Record last verified: 2007-01