| Trial ID: | L0744 |
| Source ID: | NCT01356966
|
| Associated Drug: |
Tetrahydrobiopterin
|
| Title: |
Exercise Intolerance in Renal Failure
|
| Acronym: |
EIRF
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01356966/results
|
| Conditions: |
Kidney Failure, Chronic
|
| Interventions: |
DRUG: Tetrahydrobiopterin|DRUG: Placebo|DIETARY_SUPPLEMENT: Folate
|
| Outcome Measures: |
Primary: Change in Resting Muscle Sympathetic Nerve Activity (MSNA), Baseline, 12 weeks | Secondary: Change in Mean Central Augmentation Index (AIx), The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks., Baseline, 12 weeks|Change in Heart-rate-corrected Augmentation Index (AIx), The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks., Baseline, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Emory University | Collaborators: National Institutes of Health (NIH)|National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-05
|
| Completion Date: |
2014-05
|
| Results First Posted: |
2015-06-01
|
| Last Update Posted: |
2015-06-01
|
| Locations: |
Emory University Hospital, Atlanta, Georgia, 30322, United States|Atlanta VA Medical Center, Decatur, Georgia, 30033, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01356966
|
