Peripheral Arterial DiseasePhase 3NCT06032065
SMART Exercise for PAD
A Phase 3 study testing Supervised Treadmill Exercise, Home-Based Exercise and Nitrate-rich beetroot Juice in people with Peripheral Arterial Disease and Aging, run by Northwestern University at 3 sites in United States.
Trial summary
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Aging, Peripheral Vascular Diseases
- What is being tested?
- Supervised Treadmill Exercise, Home-Based Exercise and Nitrate-rich beetroot Juice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Sep 2023to 31 Mar 2029
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:
- An ABI <= 0.90 at baseline.
- Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
- An ABI of >0.90 and <1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
Who cannot join
- Above- or below-knee amputation
- Limb-threatening ischemia defined as an ABI <0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a condition other than PAD
- Current foot ulcer on bottom of foot
- Unwilling to drink beetroot juice
Show all 27Show fewer
- Unwilling to accept randomization into either group (home based exercise or supervised exercise)
- Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking exercise activity during the trial.
- Already exercising at a level consistent with exercise intervention.
- End-stage kidney disease (ESKD) associated with the need for dialysis.
- Planned major surgery, coronary or leg revascularization during the next six months
- Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
- Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.]
- Mini-Mental Status Examination (MMSE) score < 23 or dementia. However, if the MMSE is < 23 and the Principal Investigator evaluation determines that the lower score is related to language barriers or education level, the Principal Investigator has discretion to allow a participant with MMSE < 23 to participate, as appropriate.
- Allergy to beetroot juice
- Currently consuming beetroot juice or oral nitrate or nitrite, or a beetroot supplement, and/or unwilling to avoid these during study participation. Participants currently consuming one cup of beets daily will be asked to discontinue beet ingestion for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more, they will not be eligible for the clinical trial.
- Unstable angina
- Abnormal baseline stress test without subsequent clearance for exercise by physician
- Non-English speaking. The SMART PAD interventions are delivered by interventionists who do not speak non-English languages. The integrity of the clinical trial requires clear and effective communication for data collection and intervention delivery. The trial does not have staff members who are fluent in non-English languages, nor does it have the ability to translate all study materials into other languages.
- Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.] Participants in a study that involved up to three single doses of nitrate-rich beetroot juice administered on separate days may participate if a month has passed since their last dose of nitrate-rich beetroot juice.
- Visual impairment that limits walking ability.
- Baseline blood pressure <100/45.
- Participation in a supervised treadmill exercise program or cardiac rehabilitation program in previous three months.
- Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.
- An eGFR value <30 or potassium >5.0.
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
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
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Kathryn Domanchuk, BS, 312-503-6438, k-domanchuk@northwestern.edu
Mary M McDermott, MD
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Tamar Polonsky, MD, 773-702-6153, tpolonsky@bsd.uchicago.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Diane Treat-Jacobson, PhD, 612-624-7613, treat001@umn.edu
About this study
Official title: Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for Peripheral Artery Disease: The SMART PAD Trial
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. Walking exercise is first line therapy to improve walking distance for PAD, but it does not eliminate ischemic leg symptoms in most people with PAD. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. Participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
Read the detailed description
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. As of 2018, only 1.3% of patients with Medicare and symptomatic PAD had enrolled in SET. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. In 2021, the investigators reported that a home-based exercise intervention that incorporated behavioral methods significantly improved six-minute walk in PAD, compared to an attention control group. But no randomized trials have compared SET to a home-based exercise intervention that incorporated behavioral change methods in PAD. However, 45% of people with PAD do not meaningfully respond to exercise interventions, defined as failure to improve six-minute walk by > 20 meters. This phenomenon occurs for both supervised and home-based exercise. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. Therefore, the investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. In this 2 x 2 factorial design, participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
- Being tested
- Supervised Treadmill Exercise, Home-Based Exercise, Nitrate-rich beetroot Juice
- Keywords
- behavior change, patient reported outcome measure
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Treadmill ExerciseBehavioural
This is a 12 week intervention where participants will walk for exercise 3 times a week on a treadmill at a center while being supervised by healthcare personnel.
Home-Based ExerciseBehavioural
This is a 12 week intervention where participants will walk at home for exercise with guidance from a study coach. They will have 4 in person visits in the first four weeks and then have weekly phone calls in the last 8 weeks of the intervention with their coach.
Nitrate-rich beetroot JuiceDietary supplement
Participants will drink one shot of nitrate rich beet-root juice twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Supervised treadmill exercise + nitrate rich beetroot juice | Experimental | This group will be participating in Supervised Treadmill Exercise and drinking nitrate rich beetroot juice for 12 weeks. Receives: Behavioral: Supervised Treadmill Exercise; Dietary Supplement: Nitrate-rich beetroot Juice |
| Supervised treadmill exercise + placebo | Placebo comparator | This group will be participating in Supervised Treadmill Exercise and drinking placebo beetroot juice with nitrate removed for 12 weeks. Receives: Behavioral: Supervised Treadmill Exercise |
| Home-based walking exercise + nitrate rich beetroot juice | Experimental | This group will be participating in Home-Based Exercise and drinking nitrate rich beetroot juice for 12 weeks. Receives: Behavioral: Home-Based Exercise; Dietary Supplement: Nitrate-rich beetroot Juice |
| Home-based walking exercise + placebo | Placebo comparator | This group will be participating in Home-Based Exercise and drinking placebo beetroot juice with nitrated removed for 12 weeks. Receives: Behavioral: Home-Based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Distance
Change in six-minute walk distance
Measured: Measured at baseline and 12 week follow-up
Secondary outcomes (5)
Walking Impairment Questionnaire (WIQ) Distance Score
WIQ distance score - Range 0-100, 100 is best.
Measured: measured at baseline and 12 weeks
PROMIS Mobility Questionnaire Score
PROMIS mobility score from administered PROMIS questionnaire. Score range is from zero to infinity and a higher score means a better outcome.
Measured: measured at baseline and 12 weeks
20-meter Improvement in Six-Minute Walk Distance
Meaningful response to exercise interventions
Measured: measured at 12 weeks
Step Count
Step count measured over seven days with the FITBIT
Measured: measured at baseline and 12 weeks
Six-Minute Walk Distance
Change in six-minute walk distance
Measured: Measured at baseline and 24-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start8 Sep 2023
- Primary completion1 Nov 2028 (estimated)
- Study completion31 Mar 2029 (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 Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. In this 2 x 2 factorial design, participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032065
- Sponsor's protocol ID
- STU00218112
- Status last verified
- Apr 2026
- First submitted
- 22 May 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
PubMed 42035974
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for Peripheral Artery Disease: The SMART PAD Trial
- ClinicalTrials.gov ID
- NCT06032065
- Acronym / sponsor ID
- STU00218112
- Keywords
- behavior change, patient reported outcome measure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 11 Sep 2023 (actual)
- 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.
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. Walking exercise is first line therapy to improve walking distance for PAD, but it does not eliminate ischemic leg symptoms in most people with PAD. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. Participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
Detailed description
Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. As of 2018, only 1.3% of patients with Medicare and symptomatic PAD had enrolled in SET. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. In 2021, the investigators reported that a home-based exercise intervention that incorporated behavioral methods significantly improved six-minute walk in PAD, compared to an attention control group. But no randomized trials have compared SET to a home-based exercise intervention that incorporated behavioral change methods in PAD. However, 45% of people with PAD do not meaningfully respond to exercise interventions, defined as failure to improve six-minute walk by > 20 meters. This phenomenon occurs for both supervised and home-based exercise. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. Therefore, the investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. In this 2 x 2 factorial design, participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. In this 2 x 2 factorial design, participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.
| Arm | Type | Receives |
|---|---|---|
| Supervised treadmill exercise + nitrate rich beetroot juice | Experimental | Behavioral: Supervised Treadmill Exercise, Dietary Supplement: Nitrate-rich beetroot JuiceThis group will be participating in Supervised Treadmill Exercise and drinking nitrate rich beetroot juice for 12 weeks. |
| Supervised treadmill exercise + placebo | Placebo comparator | Behavioral: Supervised Treadmill ExerciseThis group will be participating in Supervised Treadmill Exercise and drinking placebo beetroot juice with nitrate removed for 12 weeks. |
| Home-based walking exercise + nitrate rich beetroot juice | Experimental | Behavioral: Home-Based Exercise, Dietary Supplement: Nitrate-rich beetroot JuiceThis group will be participating in Home-Based Exercise and drinking nitrate rich beetroot juice for 12 weeks. |
| Home-based walking exercise + placebo | Placebo comparator | Behavioral: Home-Based ExerciseThis group will be participating in Home-Based Exercise and drinking placebo beetroot juice with nitrated removed for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:
- An ABI <= 0.90 at baseline.
- Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.
- An ABI of >0.90 and <1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
Key exclusion criteria (27 listed)
- Above- or below-knee amputation
- Limb-threatening ischemia defined as an ABI <0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a condition other than PAD
- Current foot ulcer on bottom of foot
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 |
|---|---|---|
| Supervised Treadmill ExerciseThis is a 12 week intervention where participants will walk for exercise 3 times a week on a treadmill at a center while being supervised by healthcare personnel. | Behavioural | Supervised treadmill exercise + nitrate rich beetroot juice, Supervised treadmill exercise + placebo |
| Home-Based ExerciseThis is a 12 week intervention where participants will walk at home for exercise with guidance from a study coach. They will have 4 in person visits in the first four weeks and then have weekly phone calls in the last 8 weeks of the intervention with their coach. | Behavioural | Home-based walking exercise + nitrate rich beetroot juice, Home-based walking exercise + placebo |
| Nitrate-rich beetroot JuiceParticipants will drink one shot of nitrate rich beet-root juice twice daily for 12 weeks. | Dietary supplement | Home-based walking exercise + nitrate rich beetroot juice, Supervised treadmill exercise + nitrate rich beetroot juice |
Primary outcome
Six-Minute Walk Distance
Time frame: Measured at baseline and 12 week follow-up
Change in six-minute walk distance
5 secondary outcomes
Walking Impairment Questionnaire (WIQ) Distance Score
Time frame: measured at baseline and 12 weeks
PROMIS Mobility Questionnaire Score
Time frame: measured at baseline and 12 weeks
20-meter Improvement in Six-Minute Walk Distance
Time frame: measured at 12 weeks
Step Count
Time frame: measured at baseline and 12 weeks
Six-Minute Walk Distance
Time frame: Measured at baseline and 24-week follow up
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 15 Apr 2026.
- Derived from this study: PubMed 42035974McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
Related trials for Peripheral Arterial Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supervised Treadmill Exercise, Home-Based Exercise and Nitrate-rich beetroot Juice in people with Peripheral Arterial Disease and Aging, run by Northwestern 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 4 inclusion and 27 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 15 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mary McDermott, MD (312-503-6438, mdm608@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Distance (time frame: Measured at baseline and 12 week follow-up). 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 NCT06032065, 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 15 Apr 2026.