Proteolytic Enzyme Induction Within the Human Myocardial Interstitium (NCT00744211) | Clinical Trial Compass
CompletedNot Applicable
Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
United States29 participantsStarted 2008-07
Plain-language summary
A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>60 years of age
* Body mass index \<40 kg/m2
* Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram
* Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB.
* If diabetic, be under proper control, (fasting glucose \<350 mg/dL or recent hemoglobin A1c \[HgbA1c\] \<9%).
* If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days.
* Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years
* The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination
Exclusion Criteria:
* Emergent revascularization
* Previous stroke or thrombo-embolic event in the 3 months prior to study entry
* A previous myocardial infarction within the last 7 days
* Documented coagulopathy
* Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) \> 1.5 times the upper limit of normal
* Patient is pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.