Trial Outcomes & Findings for Role of Nitric Oxide in the Impact of Aging on Myocardial Remodeling (NCT NCT00603720)

Last Updated: 2018-09-12

Results Overview

Determine in young healthy volunteers the extent to which acute inhibition of nitric oxide production will effect a shift in myocardial substrate utilization characterized as a decline in myocardial fatty acid oxidation, and perhaps myocardial fatty acid utilization, and increase in myocardial glucose uptake, and whether these changes are associated with a decline in LV function.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

1-3 months

Results posted on

2018-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	L-Name in Young 20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME. L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging	Phenylephrine 25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study	L-arginine in Young 20 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days L-Arginine: aids in nitric oxide production	L-arginine in Old 20 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days L-Arginine: aids in nitric oxide production	L-NAME in Old 20 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging
Overall Study STARTED	10	10	12	10	12
Overall Study COMPLETED	10	10	12	10	12
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	L-Name in Young n=10 Participants 20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME. L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging	Phenylephrine n=10 Participants 25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days Phenylephrine: alpha agonist; 10 μg/kg/min infusion during PET study	L-arginine in Young n=12 Participants 20 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days L-Arginine: aids in nitric oxide production	L-arginine in Old n=10 Participants 20 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days L-Arginine: aids in nitric oxide production	L-NAME in Old n=12 Participants 20 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME L-NAME: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	10 Participants n=10 Participants	12 Participants n=12 Participants	10 Participants n=10 Participants	12 Participants n=12 Participants	54 Participants n=54 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=54 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	10 Participants n=10 Participants	12 Participants n=12 Participants	10 Participants n=10 Participants	12 Participants n=12 Participants	54 Participants n=54 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	12 participants n=12 Participants	10 participants n=10 Participants	12 participants n=12 Participants	54 participants n=54 Participants

PRIMARY outcome

Timeframe: 1-3 months

Population: PI left institution. Efforts were made to access the data, without success so there is no access to the data.