Vasodilatory Hypotension During or After Cardiac SurgeryPhase 4NCT06487585
ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)
A Phase 4 study testing Angiotensin II in people with Vasodilatory Hypotension During or After Cardiac Surgery, run by University of Maryland St. Joseph Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vasodilatory Hypotension During or After Cardiac Surgery
- What is being tested?
- Angiotensin II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2025to Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years of age undergoing cardiac surgery requiring CPB
- Patients must have clinical features of vasodilation as determined by a MAP < 65 mmHg that is non-transient in the opinion of the treating physician
- Patients must be adequately volume resuscitated in the opinion of the treating physician
- Systemic Vascular Resistance index (SVRi) < 1970 dynes·sec/cm⁵/m² to support the clinical diagnosis of vasodilation; if no pulmonary artery catheter is in place, vasodilatory hypotension diagnosis according to the judgement of the critical care team
- Biventricular systolic function is at or greater than pre-cardiopulmonary bypass baseline as demonstrated by echocardiographic evaluation, or the patient is concomitantly treated with
Who cannot join
- Bleeding as primary etiology of hypotension, as determined by > 4 units RBC transfusion in 24 hours.
- Patients on ECMO
- Patients with active endocarditis
- Patients already on renal replacement therapy or creatinine of > 4 mg/dl within 2 weeks of surgery
- Patients with contraindications to Angiotensin II including women who are pregnant or breastfeeding or have active coronary ischemia, mesenteric ischemia, limb ischemia, or high potassium (> 5.5 meq/L) while receiving Angiotensin II
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21204
Sam Rudow, 410-427-5459, samuel.rudow@umm.edu
Rawn Salenger, MD
About this study
Official title: Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery (ANG-First Trial)
The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.
- Being tested
- Angiotensin II
- Keywords
- Vasodilation, Hypotension, Cardiopulmonary Bypass, Cardiac Surgery
- Medical subject headings
- Aneurysm, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin IIDrug
Angiotensin II: Starting dose of 2.5 ng/kg/min administered IV; may dose escalate up to 80 ng/kg/min in order to achieve a MAP of 65 mmHg or higher in the first 3 hours. After 3 hours, may escalate dose up to 40 ng/kg/min in order to achieve a MAP of 65 mmHg. Dose titration in increments of 10 ng/kg/min every 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Study Drug Arm - Angiotensin II arm | Other | Angiotensin II Receives: Drug: Angiotensin II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative acute kidney injury, atrial fibrillation
The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury
Measured: 28 days
Secondary outcomes (7)
Hours on Vasopressors
Measured: 28 days
Total IVF
Measured: 28 days
ICU LOS
Measured: 28 days
Postoperative LOS
Measured: 28 days
Any major STS complication
Measured: 28 days
30-day mortality
Measured: 30 days
Cost
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start6 May 2025
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasodilatory Hypotension During or After Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland St. Joseph Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- La Jolla Pharmaceutical Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487585
- Sponsor's protocol ID
- 00109542
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery (ANG-First Trial)
- ClinicalTrials.gov ID
- NCT06487585
- Acronym / sponsor ID
- 00109542
- Keywords
- Vasodilation, Hypotension, Cardiopulmonary Bypass, Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland St. Joseph Medical CenterUniversity, hospital or other
- Collaborators
- La Jolla Pharmaceutical Company
- Study start
- 6 May 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the use of Angiotensin II in patients with low blood pressure post-surgery. Your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Drug Arm - Angiotensin II arm | Other | Drug: Angiotensin IIAngiotensin II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients ≥ 18 years of age undergoing cardiac surgery requiring CPB
- Patients must have clinical features of vasodilation as determined by a MAP < 65 mmHg that is non-transient in the opinion of the treating physician
- Patients must be adequately volume resuscitated in the opinion of the treating physician
- Systemic Vascular Resistance index (SVRi) < 1970 dynes·sec/cm⁵/m² to support the clinical diagnosis of vasodilation; if no pulmonary artery catheter is in place, vasodilatory hypotension diagnosis according to the judgement of the critical care team
- Biventricular systolic function is at or greater than pre-cardiopulmonary bypass baseline as demonstrated by echocardiographic evaluation, or the patient is concomitantly treated with
Key exclusion criteria (5 listed)
- Bleeding as primary etiology of hypotension, as determined by > 4 units RBC transfusion in 24 hours.
- Patients on ECMO
- Patients with active endocarditis
- Patients already on renal replacement therapy or creatinine of > 4 mg/dl within 2 weeks of surgery
- Patients with contraindications to Angiotensin II including women who are pregnant or breastfeeding or have active coronary ischemia, mesenteric ischemia, limb ischemia, or high potassium (> 5.5 meq/L) while receiving Angiotensin II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin IIAngiotensin II: Starting dose of 2.5 ng/kg/min administered IV; may dose escalate up to 80 ng/kg/min in order to achieve a MAP of 65 mmHg or higher in the first 3 hours. After 3 hours, may escalate dose up to 40 ng/kg/min in order to achieve a MAP of 65 mmHg. Dose titration in increments of 10 ng/kg/min every 2 minutes. | Drug | Study Drug Arm - Angiotensin II arm |
Primary outcome
Incidence of postoperative acute kidney injury, atrial fibrillation
Time frame: 28 days
The primary endpoint will be measured by comparing the incidence of new-onset atrial fibrillation or acute kidney injury
7 secondary outcomes
Hours on Vasopressors
Time frame: 28 days
Total IVF
Time frame: 28 days
ICU LOS
Time frame: 28 days
Postoperative LOS
Time frame: 28 days
Any major STS complication
Time frame: 28 days
30-day mortality
Time frame: 30 days
Cost
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angiotensin II in people with Vasodilatory Hypotension During or After Cardiac Surgery, run by University of Maryland St. Joseph Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aja Janyavula (410-427-5459, ajanyavula@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative acute kidney injury, atrial fibrillation (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.