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Role of Nitric Oxide in the Impact of Aging on Myocardial Remodeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00603720
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Cardiovascular Diseases
Interventions Drug: L-NAME
Drug: L-Arginine
Drug: Phenylephrine
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old
Hide Arm/Group Description

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

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

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

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

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

Period Title: Overall Study
Started 10 10 12 10 12
Completed 10 10 12 10 12
Not Completed 0 0 0 0 0
Arm/Group Title L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old Total
Hide Arm/Group Description

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

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 10 10 12 10 12 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 12 participants 10 participants 12 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
12
 100.0%
10
 100.0%
12
 100.0%
54
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 12 participants 10 participants 12 participants 54 participants
Female
10
 100.0%
10
 100.0%
12
 100.0%
10
 100.0%
12
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 12 participants 10 participants 12 participants 54 participants
10 10 12 10 12 54
1.Primary Outcome
Title Effect of NO Inhibition on Myocardial Substrate Metabolism in Humans
Hide Description 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.
Time Frame 1-3 months
Hide Outcome Measure Data
Hide Analysis Population Description
PI left institution. Efforts were made to access the data, without success so there is no access to the data.
Arm/Group Title L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old
Hide Arm/Group Description:

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

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

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

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

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 Number of Participants Analyzed 10 10 12 10 12
Mean (90% Confidence Interval)
Unit of Measure: percentage of substrate
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
PI left institution. There is no access to the data.
Time Frame 1 to 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old
Hide Arm/Group Description

10 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

10 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

12 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

12 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

10 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

All-Cause Mortality
L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
L-Name in Young Phenylephrine L-arginine in Young L-arginine in Old L-NAME in Old
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
Organization: Washington University School of Medicine
Phone: 314-747-3877
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00603720     History of Changes
Other Study ID Numbers: AG0086
5R01AG015466-08 ( U.S. NIH Grant/Contract )
05-0810 ( Registry Identifier: HRPO )
RDRC# 482F ( Other Identifier: RDRC )
GCRC# 1002 ( Other Identifier: GCRC )
First Submitted: January 16, 2008
First Posted: January 29, 2008
Results First Submitted: February 6, 2018
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018