Can a Blood-Vessel drug shield weak hearts during surgery?
NCT ID NCT00744211
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study tests whether giving a drug called sitaxsentan during and after heart bypass surgery can improve blood flow and heart function in patients with a weakened heart (low ejection fraction). The drug blocks a hormone that can narrow blood vessels and strain the heart after surgery. Participants receive either a low dose, a higher dose, or a placebo (saline) around the time of surgery, and researchers measure how well the heart's blood vessels respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sitaxsentan sodium (an experimental drug that blocks a hormone involved in blood vessel narrowing)
- What this could lead to
- If it works, this could point toward a way to protect the heart and improve recovery in people with weak hearts undergoing bypass surgery.
- What could go wrong
- This is a small, early-stage study, so results may not apply to everyone. The drug may not improve outcomes and could have side effects, especially related to blood pressure or liver function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
29 people
The number who actually took part.
- Started
-
Jul 2008
- Finished
-
Apr 2013
- Lead sponsor
-
A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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