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Can a Blood-Vessel drug shield weak hearts during surgery?

NCT ID NCT00744211

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Show the full entry requirements

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.