100 Participants Needed

Angiotensin II for Low Blood Pressure

CR
AJ
SR
Overseen BySam Rudow
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Maryland St. Joseph Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Angiotensin II for individuals with low blood pressure following heart surgery. The goal is to assess the safety and effectiveness of this medication in aiding patients who experience a drop in blood pressure due to overly relaxed blood vessels. Candidates for this trial include those who have undergone heart surgery and continue to experience low blood pressure despite receiving fluids to increase blood volume. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for this treatment?

Research has shown that Angiotensin II can effectively raise blood pressure in individuals with hypotension. One study found that it increased mean arterial pressure from 63.3 to 78.1 mmHg. Another study demonstrated that it helped raise blood pressure in 93.8% of patients with low blood pressure following non-heart-related surgery.

Regarding safety, Angiotensin II is generally well-tolerated and has been used in patients whose low blood pressure did not respond to other treatments. Since this trial is in Phase 4, Angiotensin II has already received approval for other uses, indicating a good safety record. However, like any medication, side effects may occur, so discussing these with the study team is important.12345

Why are researchers enthusiastic about this study treatment?

Angiotensin II is unique because it directly targets and increases blood pressure by narrowing blood vessels, which is different from most other treatments for low blood pressure that typically focus on increasing blood volume or heart rate. This direct mechanism of action offers a rapid and controlled response, potentially providing quicker stabilization for patients in critical conditions. Researchers are excited about Angiotensin II because it could offer a more efficient and targeted approach to managing low blood pressure, especially in emergency settings.

What is the effectiveness track record for Angiotensin II in treating low blood pressure post-surgery?

Research has shown that Angiotensin II, which participants in this trial will receive, can effectively raise blood pressure in patients. One study increased the average blood pressure by 23.4%, from 63.3 to 78.1 mmHg. Another study found that Angiotensin II restored systolic blood pressure (the pressure when the heart beats) to near-normal levels in 93.8% of patients after surgery. It has also successfully treated patients with vasodilatory shock, a condition where blood pressure drops too low despite other treatments. These findings demonstrate that Angiotensin II effectively manages low blood pressure, especially when other methods fail.12367

Are You a Good Fit for This Trial?

The ANG-First Trial is for patients who have undergone cardiac surgery and are experiencing low blood pressure afterward. Specific details about inclusion and exclusion criteria were not provided, so it's important to consult the trial team for more information on who can participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Angiotensin II as a first-line vasopressor therapy post-surgery

Immediate post-surgery period

Follow-up

Participants are monitored for safety events and complications, including incidence of acute kidney injury and atrial fibrillation

28 days

What Are the Treatments Tested in This Trial?

Interventions

  • Angiotensin II

Trial Overview

This study is testing Angiotensin II as a first-line treatment for managing low blood pressure in patients after cardiac surgery. Participants' health will be monitored for 28 days following surgery to track safety and any complications related to the drug.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Study Drug Arm - Angiotensin II armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland St. Joseph Medical Center

Lead Sponsor

Trials
3
Recruited
250+

La Jolla Pharmaceutical Company

Industry Sponsor

Trials
24
Recruited
2,700+

Citations

The effect of angiotensin II on blood pressure in patients ...

For the 276 patients with complete data, MAP rose by 23.4% from 63.3 mmHg to 78.1 mmHg in response to Ang II (dose range: 15 ng/kg/min to 60 mcg ...

Angiotensin II treatment of hypotension in noncardiac surgery

Ang II successfully increased SBP to within 5% of baseline in 93.8% (15/16) of patients. One patient did not reach the treatment goal. The ...

Angiotensin II for the Treatment of Vasodilatory Shock

Angiotensin II effectively increased blood pressure in patients with vasodilatory shock that did not respond to high doses of conventional vasopressors.

Angiotensin Type 2 Receptor-Mediated Hypotension in ...

BP was 119±3 mm Hg during the control period, decreased to 86±6 mm Hg during 3 days of VAL alone, (P<0.00001) and decreased further to 65±7 mm Hg (P<0.001 from ...

An index of the initial blood pressure response to angiotensin ...

Eighty-six (88.7%) of the 97 angiotensin-II responsive patients achieved the hr3 efficacy endpoint versus 28/66 (42.4%) resistant patients ( ...

Angiotensin II for the treatment of vasodilatory shock

Angiotensin II effectively increased blood pressure in patients with vasodilatory shock receiving high-dose vasopressors.

Comparative First-Line Effectiveness and Safety of ACE ...

We compared the real-world effectiveness and safety of ACE inhibitors versus ARBs in the first-line treatment of hypertension.