Renal Insufficiency, ChronicPhase 2NeurovExNCT02947750
Neurovascular Transduction During Exercise in Chronic Kidney Disease
A Phase 2 study testing 6R-BH4, Folic acid and Exercise training in people with Renal Insufficiency, Chronic, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- 6R-BH4, Folic acid and Exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2016to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage III or IV Chronic Kidney Disease, defined as reduction in estimated glomerular filtration rate (eGFR) to 15-59 cc/minute as calculated by the modified Modification of Diet in Renal Disease (MDRD) Study equation or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Stable renal function, with no greater than a 30% reduction in eGFR over the prior 3 months
- Does not exercise regularly (defined as exercising less than 20 minutes twice per week)
- Willing and able to cooperate with the study protocol
- Does not exercise regularly (defined as exercising less than 20 minutes twice per week)
- Willing and able to cooperate with the study protocol
Who cannot join
- severe CKD (eGFR<15 cc/minute)
- ongoing drug or alcohol abuse
- diabetic neuropathy
- any serious systemic disease that might influence survival
- severe anemia with hgb level <9 g/dL
- clinical evidence of congestive heart failure or ejection fraction below 35%
Show all 13Show fewer
- symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
- treatment with central alpha agonists (clonidine)
- uncontrolled hypertension with BP greater than 170/100 mm Hg
- low blood pressure with BP less than 100/50
- pregnancy or plans to become pregnant
- current treatment with monoamine oxidase (MAO) inhibitors
- inability to exercise on a stationary bicycle
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Dana DaCosta, 404-727-7762, drdacos@emory.edu
Jeanie Park, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Dana DaCosta, 404-727-7762, drdacos@emory.edu
Jeanie Park, MD
- Recruiting
Atlanta VA Health Care System
Decatur, Georgia, 30033
Dana DaCosta, 404-727-7762, drdacos@emory.edu
Melanie Kankam, 404-321-6111 ext. 7040, mljeffe@emory.edu
About this study
Official title: Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and/or treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.
Read the detailed description
The major problem addressed in this study is to understand mechanisms underlying poor exercise capacity in patients with chronic kidney disease (CKD). Prior research has found that CKD patients have an exaggerated increase in blood pressure during certain forms of exercise that could contribute to exercise dysfunction as well as cardiovascular disease. This study will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of simple measures such as exercise training on a stationary bicycle, and treatment with 6R-BH4, a drug that is currently FDA-approved for the treatment of phenylketonuria, but has been shown to have beneficial effects on vascular health in patients with kidney disease. This study will also examine the effects of exercise with histidine and beta-alanine supplementation. Histidine and beta-alanine are two over-the-counter supplements commonly used to enhance sports performance in athletes.
Prior to the intervention portion of this study, the researchers will measure how much the vein constricts in response to adrenaline in CKD patients versus controls. The study will also measure muscle pH, and muscle oxygenation during exercise in CKD patients and controls.
The intervention portion of the study will test whether aerobic exercise training with and without 6R-BH4, or with and without histidine and beta-alanine supplementation might help muscle pH and adrenaline levels, vascular reactivity, muscle oxygenation, and the exaggerated blood pressure response during exercise in CKD patients. Participants will be randomized using a 2x2 factorial design to exercise training (ET) with 6R-BH4, ET with placebo, stretching (control condition to exercise) with 6R-BH4, and stretching with placebo. Participants will undergo exercise training on a stationary bicycle, or stretching exercises, 3 times per week for 6-14 weeks (depending on availability of the participant).
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- 6R-BH4, 6R-BH4 placebo, Folic acid, Exercise training, Stretching
- Keywords
- Hypertension, Kidney Disorder, Nephrology, Physiology
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6R-BH4Drug
Also called Tetrahydrobiopterin, Kuvan, Sapropterin dihydrochloride
Participants will receive 200 mg of 6R-BH4 twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food.
6R-BH4 placeboOther
Participants will receive a placebo that is identical to 200 mg of 6R-BH4. The placebo will be taken twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food.
Folic acidDietary supplement
Participants will take 1 mg of folic acid daily for 12 weeks. Folic acid is given because it enhances the binding affinity of BH4 to nitric oxide synthase (NOS), and also enhances the regeneration of BH4 from inactive BH2
Exercise trainingOther
Participants will exercise 3 times a week on a stationary ergometer. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) calculated utilizing the Karvonen method. Briefly, target exercise heart rate (HR) is calculated by subtracting the persons age from 220. Resting heart rate is then subtracted from this number. The answer is then multiplied by the target percent (50% for example) and the product is added back to resting heart rate to provide the target exercise session heart rate. Intensity will be increased by 5% every week (as tolerated by the participant) to a maximum of 80% of maximal heart rate. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week.
StretchingOther
Also called Control for exercise training
Participants randomized to 'No Exercise Training' group will instead of aerobic exercise, undergo progressive whole body stretching and toning exercises designed for individuals 65 and older. This type of low intensity activity is designed not to increase heart rate and will serve as the Control group to the Exercise Training group. The Control group will come in for stretching sessions 3 times per week for 20-45 minutes.
Histidine and beta-alanine supplementationDietary supplement
Histidine and beta-alanine are two over-the-counter supplements commonly used to enhance sports performance in athletes. Participants randomized to this study arm will receive combined histidine (4g/day) and beta-alanine (3.2g/day) supplementation.
Histidine and beta-alanine placeboOther
Participants randomized to this study arm will receive a placebo to match combined histidine (4g/day) and beta-alanine (3.2g/day) supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training + 6R-BH4 | Experimental | Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4. Receives: Drug: 6R-BH4; Dietary Supplement: Folic acid; Other: Exercise training |
| Exercise training + 6R-BH4 placebo | Active comparator | Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the study drug 6R-BH4. Receives: Other: 6R-BH4 placebo; Dietary Supplement: Folic acid; Other: Exercise training |
| Stretching + 6R-BH4 | Active comparator | Participants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4. Receives: Drug: 6R-BH4; Dietary Supplement: Folic acid; Other: Stretching |
| Stretching + placebo | Placebo comparator | Participants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo instead of the active study drug. Receives: Other: 6R-BH4 placebo; Dietary Supplement: Folic acid; Other: Stretching |
| Exercise training + histidine and beta-alanine | Active comparator | Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take histidine and beta-alanine supplementation. Receives: Other: Exercise training; Dietary Supplement: Histidine and beta-alanine supplementation |
| Exercise training + histidine and beta-alanine placebo | Active comparator | Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the histidine and beta-alanine supplementation. Receives: Other: Exercise training; Other: Histidine and beta-alanine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional sympatholysis
Muscle oxygenation during exercise and sympathoexcitation will be measured.
Measured: Baseline, Week 12
Change in vascular alpha 1 adrenergic responsiveness
Changes in vascular diameter in response to phenylephrine will be measured.
Measured: Baseline, Week 12
Change in exaggerated pressor responses during exercise
Blood pressure and sympathetic responses during exercise will be measured.
Measured: Baseline, Week 12
Secondary outcomes (3)
Renal artery resistance during exercise
Renal artery blood flow will be measured.
Measured: Baseline, Week 12
Change in endothelial function
Endothelial function using peripheral arterial tonometry will be measured.
Measured: Baseline, Week 12
Change in vascular stiffness
Vascular stiffness using applanation tonometry.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeanie Park, Emory University
- Investigators
- Joe Nocera, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947750
- Sponsor's protocol ID
- IRB00091660
- Other IDs
- R01HL135183, 2025P010140
- Acronym
- NeurovEx
- Status last verified
- May 2026
- First submitted
- 17 Oct 2016
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeong J, Sprick JD, DaCosta DR, Mammino K, Nocera JR, Park J. Exercise modulates sympathetic and vascular function in chronic kidney disease. JCI Insight. 2023 Feb 22;8(4):e164221. doi: 10.1172/jci.insight.164221.
PubMed 36810250
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02947750
- Acronym / sponsor ID
- NeurovEx / IRB00091660
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Hypertension, Kidney Disorder, Nephrology, Physiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and/or treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.
Detailed description
The major problem addressed in this study is to understand mechanisms underlying poor exercise capacity in patients with chronic kidney disease (CKD). Prior research has found that CKD patients have an exaggerated increase in blood pressure during certain forms of exercise that could contribute to exercise dysfunction as well as cardiovascular disease. This study will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of simple measures such as exercise training on a stationary bicycle, and treatment with 6R-BH4, a drug that is currently FDA-approved for the treatment of phenylketonuria, but has been shown to have beneficial effects on vascular health in patients with kidney disease. This study will also examine the effects of exercise with histidine and beta-alanine supplementation. Histidine and beta-alanine are two over-the-counter supplements commonly used to enhance sports performance in athletes.
Prior to the intervention portion of this study, the researchers will measure how much the vein constricts in response to adrenaline in CKD patients versus controls. The study will also measure muscle pH, and muscle oxygenation during exercise in CKD patients and controls.
The intervention portion of the study will test whether aerobic exercise training with and without 6R-BH4, or with and without histidine and beta-alanine supplementation might help muscle pH and adrenaline levels, vascular reactivity, muscle oxygenation, and the exaggerated blood pressure response during exercise in CKD patients. Participants will be randomized using a 2x2 factorial design to exercise training (ET) with 6R-BH4, ET with placebo, stretching (control condition to exercise) with 6R-BH4, and stretching with placebo. Participants will undergo exercise training on a stationary bicycle, or stretching exercises, 3 times per week for 6-14 weeks (depending on availability of the participant).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Exercise training + 6R-BH4 | Experimental | Drug: 6R-BH4, Dietary Supplement: Folic acid, Other: Exercise trainingParticipants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4. |
| Exercise training + 6R-BH4 placebo | Active comparator | Other: 6R-BH4 placebo, Dietary Supplement: Folic acid, Other: Exercise trainingParticipants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the study drug 6R-BH4. |
| Stretching + 6R-BH4 | Active comparator | Drug: 6R-BH4, Dietary Supplement: Folic acid, Other: StretchingParticipants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4. |
| Stretching + placebo | Placebo comparator | Other: 6R-BH4 placebo, Dietary Supplement: Folic acid, Other: StretchingParticipants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo instead of the active study drug. |
| Exercise training + histidine and beta-alanine | Active comparator | Other: Exercise training, Dietary Supplement: Histidine and beta-alanine supplementationParticipants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take histidine and beta-alanine supplementation. |
| Exercise training + histidine and beta-alanine placebo | Active comparator | Other: Exercise training, Other: Histidine and beta-alanine placeboParticipants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the histidine and beta-alanine supplementation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage III or IV Chronic Kidney Disease, defined as reduction in estimated glomerular filtration rate (eGFR) to 15-59 cc/minute as calculated by the modified Modification of Diet in Renal Disease (MDRD) Study equation or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Stable renal function, with no greater than a 30% reduction in eGFR over the prior 3 months
- Does not exercise regularly (defined as exercising less than 20 minutes twice per week)
- Willing and able to cooperate with the study protocol
- Does not exercise regularly (defined as exercising less than 20 minutes twice per week)
Key exclusion criteria (13 listed)
- severe CKD (eGFR<15 cc/minute)
- ongoing drug or alcohol abuse
- diabetic neuropathy
- any serious systemic disease that might influence survival
- severe anemia with hgb level <9 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6R-BH4Also: Tetrahydrobiopterin, Kuvan, Sapropterin dihydrochlorideParticipants will receive 200 mg of 6R-BH4 twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food. | Drug | Exercise training + 6R-BH4, Stretching + 6R-BH4 |
| 6R-BH4 placeboParticipants will receive a placebo that is identical to 200 mg of 6R-BH4. The placebo will be taken twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food. | Other | Exercise training + 6R-BH4 placebo, Stretching + placebo |
| Folic acidParticipants will take 1 mg of folic acid daily for 12 weeks. Folic acid is given because it enhances the binding affinity of BH4 to nitric oxide synthase (NOS), and also enhances the regeneration of BH4 from inactive BH2 | Dietary supplement | Exercise training + 6R-BH4, Exercise training + 6R-BH4 placebo, Stretching + 6R-BH4, Stretching + placebo |
| Exercise trainingParticipants will exercise 3 times a week on a stationary ergometer. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) calculated utilizing the Karvonen method. Briefly, target exercise heart rate (HR) is calculated by subtracting the persons age from 220. Resting heart rate is then subtracted from this number. The answer is then multiplied by the target percent (50% for example) and the product is added back to resting heart rate to provide the target exercise session heart rate. Intensity will be increased by 5% every week (as tolerated by the participant) to a maximum of 80% of maximal heart rate. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week. | Other | Exercise training + 6R-BH4, Exercise training + 6R-BH4 placebo, Exercise training + histidine and beta-alanine, Exercise training + histidine and beta-alanine placebo |
| StretchingAlso: Control for exercise trainingParticipants randomized to 'No Exercise Training' group will instead of aerobic exercise, undergo progressive whole body stretching and toning exercises designed for individuals 65 and older. This type of low intensity activity is designed not to increase heart rate and will serve as the Control group to the Exercise Training group. The Control group will come in for stretching sessions 3 times per week for 20-45 minutes. | Other | Stretching + 6R-BH4, Stretching + placebo |
| Histidine and beta-alanine supplementationHistidine and beta-alanine are two over-the-counter supplements commonly used to enhance sports performance in athletes. Participants randomized to this study arm will receive combined histidine (4g/day) and beta-alanine (3.2g/day) supplementation. | Dietary supplement | Exercise training + histidine and beta-alanine |
| Histidine and beta-alanine placeboParticipants randomized to this study arm will receive a placebo to match combined histidine (4g/day) and beta-alanine (3.2g/day) supplementation. | Other | Exercise training + histidine and beta-alanine placebo |
Primary outcome
Change in functional sympatholysis
Time frame: Baseline, Week 12
Muscle oxygenation during exercise and sympathoexcitation will be measured.
Change in vascular alpha 1 adrenergic responsiveness
Time frame: Baseline, Week 12
Changes in vascular diameter in response to phenylephrine will be measured.
Change in exaggerated pressor responses during exercise
Time frame: Baseline, Week 12
Blood pressure and sympathetic responses during exercise will be measured.
3 secondary outcomes
Renal artery resistance during exercise
Time frame: Baseline, Week 12
Change in endothelial function
Time frame: Baseline, Week 12
Change in vascular stiffness
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 36810250Jeong J, Sprick JD, DaCosta DR, Mammino K, Nocera JR, Park J. Exercise modulates sympathetic and vascular function in chronic kidney disease. JCI Insight. 2023 Feb 22;8(4):e164221. doi: 10.1172/jci.insight.164221.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joe Nocera, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6R-BH4, Folic acid and Exercise training in people with Renal Insufficiency, Chronic, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanie Park, MD (404-727-2525, jeanie.park@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional sympatholysis (time frame: Baseline, Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.