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Heart surgery shock drug trial stalls after just two patients

NCT ID NCT04904562

Disease control Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested angiotensin II (Giapreza) as a first-line treatment for distributive shock in patients who had a heart transplant or LVAD implant. The goal was to see if it could reduce the need for other blood pressure medications. However, the trial was terminated early after enrolling only 2 out of 40 planned participants, so no meaningful conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Angiotensin II (Giapreza)
What this could lead to
If successful, this could point toward a new first-line treatment for shock after heart surgery, potentially reducing the need for other strong medications.
What could go wrong
This was a very small pilot study that ended early with only 2 participants, so results are not reliable. The drug may not work better than standard care, and side effects are possible.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2 people

The number who actually took part.

Started

Jun 2022

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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: 1. Patients (18 years of age or older) 2. Onset of distributive shock within 48 hours after heart transplantation or VAD placement. Distributive shock defined as MAP less than 55mmHg on CPB, MAP less than 70mmHg before or after CPB, or systemic vascular resistance (SVR) less than 800 dynes/cm/sec5 with cardiac index (CI) greater than 2.0L/min/m2 and clinically determined euvolemia. Exclusion Criteria: 1. Patients without distributive shock, 2. Women who are pregnant or breastfeeding. 3. Patients who do not receive the study drug as a first line agent for distributive shock 4. Allergy to angiotensin II, angiotensin II or another vasopressor being used at the time of presentation to the operating room 5. Preexisting distributive shock 6. Preexisting thromboembolic disease 7. Patients who are unwilling to provide consent

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Conditions

The condition(s) this trial relates to.

Vasoplegia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Distributive shock

Contacts and locations

Locations

  • Northwestern University

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.