ANG-First Trial (Angiotensin II as First-Line Vasopressor Therapy in Cardiac Surgery)

NCT06487585 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 00109542
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasodilatory Hypotension During or After Cardiac Surgery

Keywords

Vasodilation; Hypotension; Cardiopulmonary Bypass; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Secondary Outcomes (7)

• Hours on Vasopressors

  28 days

• Total IVF

  28 days

• ICU LOS

  28 days

• Postoperative LOS

  28 days

• Any major STS complication

  28 days

Study Arms (1)

Study Drug Arm - Angiotensin II arm

OTHER

Angiotensin II

Drug: Angiotensin II

Interventions

Angiotensin II DRUG

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 Drug Arm - Angiotensin II arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: collaborator
• University of Maryland St. Joseph Medical Center: lead

Study Sites (1)

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

RECRUITING

MeSH Terms

Conditions

Aneurysm; Hypotension

Interventions

Angiotensin II

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Aja Janyavula

CONTACT

410-427-5459; ajanyavula@umm.edu

Sam Rudow

CONTACT

410-427-5459; samuel.rudow@umm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: May 6, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)