A Randomized, Placebo-controlled, Double Blind Evaluation of the Safety and Efficacy of Angiotensin 1-7 (Ang-(1-7)) to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery.

Status: Suspended
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:

• Adult male or female first time cardiac surgical participants

• Elective on pump coronary artery bypass grafting (CABG)

• Age 60-80

• Signed, informed consent

• Geriatric Depression Scale score less than or = 14or Beck's Depression Inventory less than or = 20

• Score \> or = 25 on the Mini-Mental State Examination (MMSE)

Locations
United States
Arizona
Banner- University Medical Center Phoenix
Phoenix
University of Arizona Sarver Heart Center
Tucson
Maryland
National Institutes of Health
Bethesda
Suburban Hospital
Bethesda
Virginia
INOVA Heart & Vascular Research
Falls Church
Time Frame
Start Date: 2017-07-20
Completion Date: 2022-11-15
Participants
Target number of participants: 6
Treatments
Experimental: Angiotensin-(1-7)
Intervention: Drug: 200 mcg/kg/day injected subcutaneously once daily for 21 days
Placebo_comparator: Placebo for Angiotensin-(1-7)
Intervention: Placebo for Angiotensin-(1-7) injected subcutaneously once daily for 21 days
Sponsors
Collaborators: Suburban Hospital, National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Arizona

This content was sourced from clinicaltrials.gov