| Trial ID: | L0384 |
| Source ID: | NCT02947750
|
| Associated Drug: |
6r-Bh4
|
| Title: |
Neurovascular Transduction During Exercise in Chronic Kidney Disease
|
| Acronym: |
NeurovEx
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: 6R-BH4|OTHER: 6R-BH4 placebo|DIETARY_SUPPLEMENT: Folic acid|OTHER: Exercise training|OTHER: Stretching|DIETARY_SUPPLEMENT: Histidine and beta-alanine supplementation|OTHER: Histidine and beta-alanine placebo
|
| Outcome Measures: |
Primary: Change in functional sympatholysis, Muscle oxygenation during exercise and sympathoexcitation will be measured., Baseline, Week 12|Change in vascular alpha 1 adrenergic responsiveness, Changes in vascular diameter in response to phenylephrine will be measured., Baseline, Week 12|Change in exaggerated pressor responses during exercise, Blood pressure and sympathetic responses during exercise will be measured., Baseline, Week 12 | Secondary: Renal artery resistance during exercise, Renal artery blood flow will be measured., Baseline, Week 12|Change in endothelial function, Endothelial function using peripheral arterial tonometry will be measured., Baseline, Week 12|Change in vascular stiffness, Vascular stiffness using applanation tonometry., Baseline, Week 12
|
| Sponsor/Collaborators: |
Sponsor: Emory University | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2016-10
|
| Completion Date: |
2026-01
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-05
|
| Locations: |
Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States|Atlanta VA Health Care System, Decatur, Georgia, 30033, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02947750
|
