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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252093 on ClinicalTrials.gov