Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG
NCT03252093 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-06-04
Summary
Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with cognitive impairment. Mechanisms of cognitive impairment are complex but may include insufficient oxygenation and inflammation due to exposure to the bypass circuit. Currently there are no approved therapeutics for the prevention or treatment of cognitive impairment in these patients.
A small peptide, Angiotensin-(1-7) \[Ang-(1-7)\], is known to decrease inflammation in the brain in animal models. Early studies in humans have shown it to be safe. This peptide is naturally produced by the body and has anti-inflammatory and vasodilatory effects. Investigators believe that Ang-(1-7) may be able to help lower the risk of cognitive dysfunction in patients undergoing CABG.
The goal of this project is to explore effects of the experimental peptide Angiotensin-(1-7) (Ang-(1-7) in patients undergoing an elective CABG surgery to determine its safety and efficacy to prevent cognitive dysfunction in patients undergoing CABG.
Conditions
- Coronary Artery Bypass Surgery
- Cognitive Impairment
Interventions
- DRUG
-
Angiotensin-(1-7)
Subcutaneous injection of 200 mcg/kg/day
- DRUG
-
Placebo for Angiotensin-(1-7)
Subcutaneous injection of Placebo
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Suburban Hospital
collaborator OTHER -
University of Arizona
lead OTHER
Principal Investigators
-
Nancy K Sweitzer, MD, PhD · University of Arizona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-20
- Primary Completion
- 2022-11-15
- Completion
- 2022-11-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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