Heart FailureMUTTON-HFNCT06549699
Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure
A study testing Medically Tailored Meal Program with Traditional Navajo Foods in people with Heart Failure, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Study subjects with heart failure will receive either pre-prepared, home-delivered DASH/SRD-compliant meals incorporating local Navajo traditional foods or usual care for 60 days (14 meals weekly). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medically Tailored Meal Program with Traditional Navajo Foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- ICD I50* diagnosis
- Clinical encounter in last 12 months
- Primary care physician at the two IHS sites
- Hospitalization (any-cause) or ER visit within last 12 months
Who cannot join
- Hospice care
- Living in acute rehabilitation or skilled nursing facility
- Living outside the Gallup Service Unit (outside 50-mile catchment area)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gallup Indian Medical Center
Gallup, New Mexico, 87301
Tohatchi Health Clinic
Tohatchi, New Mexico, 87325
About this study
Official title: MUTTON-HF (Medically Used Tailored Traditional Food to Optimize Nutrition) in Heart Failure)
Study subjects with heart failure will receive either pre-prepared, home-delivered DASH/SRD-compliant meals incorporating local Navajo traditional foods or usual care for 60 days (14 meals weekly).
Read the detailed description
The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the U.S. [1] Heart failure, in particular, causes significant morbidity and mortality in Navajo Nation. For many Navajo patients, similar to other American Indian populations, food insecurity is a major driver of health disparities. [2][3] In fact, qualitative data from our heart failure patient advisory committee have found that 89% of patients with heart failure believe nutrition insecurity is a major barrier to optimal health. Dietary factors are believed to be an important cause of hospitalizations in patients with heart failure and cardiovascular outcomes. There is increasing evidence that direct dietary support, such as produce prescription or provision of medically tailored meals may improve cardiovascular outcomes and disease-specific quality of life.[4][5] Furthermore, there has been an increased focus in Indigenous communities to reclaim traditional indigenous foods to improve health. However, more evidence of the benefit of traditional Indigenous foods for cardiovascular health is needed.
The investigators, therefore, in discussion with community members and tribal partners at two Indian Health Service (IHS) sites in Navajo Nation, will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation. This study will include two phases, with a phase I pilot feasibility study, followed by phase II-a comparativeness effectiveness randomized control trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care. Phase I outcomes will include implementation outcomes such as feasibility and acceptability to inform phase II. The primary outcome for the trial in Phase II will be the proportion of patients who have a hospitalization or ER visit for any cause within 90 days post implementation. Secondary outcomes will include: heart failure hospitalizations specifically, ER visits for volume overload specifically (ER visits for lower extremity edema, dyspnea, with clinical evaluation consistent with volume overload) within 90 days, Kansas City Cardiomyopathy Questionnaire clinical summary score at baseline and at 60 days; prescription adherence rates (% of filled prescriptions out of prescriptions made) for all medication as well as GDMT specifically at 60 days, weight at baseline (and BMI) at 60 days, and the following lab parameters and biomarkers at baseline and at 60 days: albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP, and measures of food insecurity. The investigators will also collect measures of Indigenous cultural connectiveness using the validated Cultural Connectedness Scale-California (CCS-CA) at baseline and at 60 days, as well as qualitative analyses of local food suppliers to evaluate how this program strengthens local food systems. The investigators will also evaluate food diaries and perform a survey at 90 days to evaluate for any sustainable change in diet and behavior post intervention. Semi-structured interviews will be performed of stakeholders including a subset of patients, primary care providers and food suppliers to assess implementation outcomes.
- Conditions
- Heart Failure
- Being tested
- Medically Tailored Meal Program with Traditional Navajo Foods, Usual Care
- Keywords
- Indigenous, Navajo, Traditional Foods, Nutrition security, food is medicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored Meal Program with Traditional Navajo FoodsOther
Patients will receive medically-tailored meals incorporating local traditional Navajo foods
Usual CareOther
Usual care plus healthy recipes provided
| Study group | Role | What they receive |
|---|---|---|
| Meal delivery program | Active comparator | Patients will receive 2 meals daily (14 meals weekly) of medically-tailored meals incorporating traditional Navajo foods, followed by a cooking class at the end of the meal program (meals provided for 60 days). Receives: Other: Medically Tailored Meal Program with Traditional Navajo Foods |
| Usual Care | Placebo comparator | Patients will receive usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization or Emergency Department Visit
Hospitalization or Visit to Emergency Department (All-cause)
Measured: 90 days
Secondary outcomes (25)
Cultural Connectedness Scale-California
The investigators will measure cultural connectedness utilizing a 6-question modified version of the validated Cultural Connectedness Scale-California (CCS-CA) at baseline and at 60 days. This is a validated score, developed by Indigenous scholars to measure cultural connectiveness in Indigenous populations, and has been shown to correlate with physical health and be a social determinant of health. This scale has previously been modified for use in Diné populations specifically by the investigators. The investigators will evaluate total score, as well as subcomponents of identity, traditions, and spirituality.
Measured: 60 days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
This is a validated score for evaluating quality of life and symptom measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status.
Measured: 60 days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Quality of Life Subset
Subset of this is a validated score for evaluating quality of life measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status.
Measured: 60 days
Food Security
The investigators will evaluate baseline and 60-day rates of food insecurity utilizing the USDA Adult Food Security: Six Item short Form survey (USDA FSSM 6-Item).[12] At the 60-day evaluation, the investigators will adapt the USDA FSSM 6-Item questionnaire to evaluate food insecurity within the last 2 (rather than 12 months).
Measured: 60 days
Biomarker Data
albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP
Measured: 60 days
Weight
Weight (kilograms). Weight and height will be combined to report BMI in kg/m^2
Measured: 60 days
ER visits
All cause
Measured: 90 days
Hospitalizations
All cause
Measured: 90 days
ER visit for Heart Failure
ER visit for volume overload or HF symptoms
Measured: 90 days
Heart Failure hospitalization
Measured: 90 days
Diet Quality
The investigators will assess diet quality using the 10-item DSQ [11] with an addition question to assess traditional Diné food intake (During the past month, how often did the participant eat traditional Diné foods (such as blue corn mush, steamed, roasted or dried corn, sumac berries, mutton, local varieties of squash or beans) at baseline and at the end of the intervention.
Measured: 60 Days, 90 days
Financial Stress
The investigators will measure Financial Stress Scale at baseline and at 60 days using two questions:[16] How worried was the participant over the last 2 months about paying for housing (rent, mortgage, etc.)? How worried was the participant over the last 2 months about paying monthly bills?
§ All questions will be answered on a 4-point scale, where 1 = "not worried at all", 2 = "not too worried", 3 = "moderately worried", and 4 = "very worried"
Measured: 60 Days
Intervention characteristics: Partnership
The investigators will evaluate the following:
- % of meals that include locally sourced ingredients
- % of food supply sourced by Diné producers/suppliers/farmers
- % of meals sourced by Native suppliers/farmers
Measured: 60 Days
Implementation Outcomes: Feasibility
The investigators will evaluate the percentage of meals delivered successfully to the patient (or percentage of meals that were successfully picked up by the patient if picked up from the food pantry or other location).
Measured: 60 Days
Implementation Outcomes: Fidelity
The investigators will assess baseline dietary patterns through 3-day food diaries during week 1 and week 8 after enrollment. The investigators will also survey participants on the % of meals consumed at 60 days. Additionally at 90 days, the investigators will perform a survey to evaluate dietary patterns post intervention and adoption of any of the recipes/behavioral changes.
Measured: 60 Days
Implementation Outcomes: Acceptability
The investigators will evaluate patient satisfaction by evaluating the Net Promoter Score (i.e. how likely is it that the patient would recommend this program to a community member?") post-intervention.
Measured: 60 Days
Qualitative Implementation Outcomes: Fidelity, acceptability, feasibility, adoption
The investigators will perform semi-structured interviews of non-patient stakeholders (i.e. farmers that supplied produce, livestock farmers, food pantry) to assess acceptability and feasibility of providing produce for the meals, as well as the degree to which the program contributed to strengthening the local food system. The investigators will also perform semi-structured interviews of primary care providers and a subset of patients. Semi-structured interviews will be guided by the Consolidated Framework for Implementation Research (CFIR), and the investigators will explore multiple constructs within each CFIR domain that are hypothesized by the study team and based on existing literature to be relevant to acceptability and feasibility of the program.
Measured: 60 Days
Physical Activity
The investigators will evaluate how much physical activity/exercise patients are participating in weekly at baseline, and at 60 days by asking patients to estimate the number of minutes weekly that they are participating in formal exercise or physical activity.
Measured: 60 Days
General Health Status
The investigators will evaluate patients' general health status using a single general health status question (would the patient that in general their health is excellent, very good, good, fair, or poor) at baseline and post-intervention
Measured: 60 Days
KCCQ12-PL Physical Limitation Score
Subsection of KCCQ-12 Score
Measured: 60 Days
KCCQ12-SF Symptom Frequency Score
Subsection of KCCQ12 Score
Measured: 60 Days
KCCQ-SL Social Limitation Score
Subsection of KCCQ-12 Score
Measured: 60 Days
Indigenous Nourishment Scale
The investigators will evaluate the Indigenous Nourishment Scale (Measure A), which is a scale developed through community-based methods in Indigenous communities to encompass multiple dimensions of nourishment. The investigators will assign score of 0-6 for each response (0 for never-6 for always), for a total score 0-54 (with 0 meaning low levels of nourishment and 54 high levels of nourishment.
Measured: Baseline, 60 days
Height
Height (cm). Weight and height will be combined to report BMI in kg/m^2.
Measured: 60 days
urine albumin:creatinine
Urine albumin:creatinine ratio
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start12 May 2025
- Primary completion11 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Health Service (IHS), American Heart Association, Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Lauren Eberly, MD, MPH, Principal investigator, Indian Health Service (IHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549699
- Sponsor's protocol ID
- 08072024
- Acronym
- MUTTON-HF
- Status last verified
- Dec 2025
- First submitted
- 8 Aug 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eberly LA, George C, Sandman S, Bex D, Jones K, Yazzie A, Gray L, Morgan L, Tennison A, Williams C, Chandra M, Wickre R, Wickre B, Bolas M, Welbel R, Ignace D, Feliciano B, Hammer S, Damon-Mallette D, Lindsey E, Mora P, Ye A, Merino M, Schisterman EF, Shin SS. An Indigenous Food Is Medicine Intervention: The MUTTON-HF Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 27:e262879. doi: 10.1001/jamainternmed.2026.2879. Online ahead of print.
PubMed 42507456Eberly LA, George C, Sandman S, Bex D, Jones K, Yazzie A, Gray L, Morgan L, Tennison A, Williams C, Chandra M, Wickre R, Wickre B, Bolas M, Welbel R, Ignace D, Feliciano B, Damon-Mallette D, Lindsey E, Mora P, Merino M, Schisterman EF, Shin SS. MUTTON-HF: Rationale and Design of a Study of an Indigenous Food is Medicine Intervention. Circ Heart Fail. 2026 Apr;19(4):e014013. doi: 10.1161/CIRCHEARTFAILURE.125.014013. Epub 2026 Mar 2.
PubMed 41766529
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUTTON-HF (Medically Used Tailored Traditional Food to Optimize Nutrition) in Heart Failure)
- ClinicalTrials.gov ID
- NCT06549699
- Acronym / sponsor ID
- MUTTON-HF / 08072024
- Conditions
- Heart Failure
- Keywords
- Indigenous, Navajo, Traditional Foods, Nutrition security, food is medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Indian Health Service (IHS), American Heart Association, Brigham and Women's Hospital
- Study start
- 12 May 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Aug 2024 (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.
Study subjects with heart failure will receive either pre-prepared, home-delivered DASH/SRD-compliant meals incorporating local Navajo traditional foods or usual care for 60 days (14 meals weekly).
Detailed description
The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the U.S. [1] Heart failure, in particular, causes significant morbidity and mortality in Navajo Nation. For many Navajo patients, similar to other American Indian populations, food insecurity is a major driver of health disparities. [2][3] In fact, qualitative data from our heart failure patient advisory committee have found that 89% of patients with heart failure believe nutrition insecurity is a major barrier to optimal health. Dietary factors are believed to be an important cause of hospitalizations in patients with heart failure and cardiovascular outcomes. There is increasing evidence that direct dietary support, such as produce prescription or provision of medically tailored meals may improve cardiovascular outcomes and disease-specific quality of life.[4][5] Furthermore, there has been an increased focus in Indigenous communities to reclaim traditional indigenous foods to improve health. However, more evidence of the benefit of traditional Indigenous foods for cardiovascular health is needed.
The investigators, therefore, in discussion with community members and tribal partners at two Indian Health Service (IHS) sites in Navajo Nation, will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation. This study will include two phases, with a phase I pilot feasibility study, followed by phase II-a comparativeness effectiveness randomized control trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care. Phase I outcomes will include implementation outcomes such as feasibility and acceptability to inform phase II. The primary outcome for the trial in Phase II will be the proportion of patients who have a hospitalization or ER visit for any cause within 90 days post implementation. Secondary outcomes will include: heart failure hospitalizations specifically, ER visits for volume overload specifically (ER visits for lower extremity edema, dyspnea, with clinical evaluation consistent with volume overload) within 90 days, Kansas City Cardiomyopathy Questionnaire clinical summary score at baseline and at 60 days; prescription adherence rates (% of filled prescriptions out of prescriptions made) for all medication as well as GDMT specifically at 60 days, weight at baseline (and BMI) at 60 days, and the following lab parameters and biomarkers at baseline and at 60 days: albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP, and measures of food insecurity. The investigators will also collect measures of Indigenous cultural connectiveness using the validated Cultural Connectedness Scale-California (CCS-CA) at baseline and at 60 days, as well as qualitative analyses of local food suppliers to evaluate how this program strengthens local food systems. The investigators will also evaluate food diaries and perform a survey at 90 days to evaluate for any sustainable change in diet and behavior post intervention. Semi-structured interviews will be performed of stakeholders including a subset of patients, primary care providers and food suppliers to assess implementation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal delivery program | Active comparator | Other: Medically Tailored Meal Program with Traditional Navajo FoodsPatients will receive 2 meals daily (14 meals weekly) of medically-tailored meals incorporating traditional Navajo foods, followed by a cooking class at the end of the meal program (meals provided for 60 days). |
| Usual Care | Placebo comparator | Other: Usual CarePatients will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 years
- ICD I50* diagnosis
- Clinical encounter in last 12 months
- Primary care physician at the two IHS sites
- Hospitalization (any-cause) or ER visit within last 12 months
Key exclusion criteria (3 listed)
- Hospice care
- Living in acute rehabilitation or skilled nursing facility
- Living outside the Gallup Service Unit (outside 50-mile catchment area)
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 |
|---|---|---|
| Medically Tailored Meal Program with Traditional Navajo FoodsPatients will receive medically-tailored meals incorporating local traditional Navajo foods | Other | Meal delivery program |
| Usual CareUsual care plus healthy recipes provided | Other | Usual Care |
Primary outcome
Hospitalization or Emergency Department Visit
Time frame: 90 days
Hospitalization or Visit to Emergency Department (All-cause)
25 secondary outcomes
Cultural Connectedness Scale-California
Time frame: 60 days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: 60 days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Quality of Life Subset
Time frame: 60 days
Food Security
Time frame: 60 days
Biomarker Data
Time frame: 60 days
Weight
Time frame: 60 days
ER visits
Time frame: 90 days
Hospitalizations
Time frame: 90 days
ER visit for Heart Failure
Time frame: 90 days
Heart Failure hospitalization
Time frame: 90 days
Diet Quality
Time frame: 60 Days, 90 days
Financial Stress
Time frame: 60 Days
Intervention characteristics: Partnership
Time frame: 60 Days
Implementation Outcomes: Feasibility
Time frame: 60 Days
Implementation Outcomes: Fidelity
Time frame: 60 Days
Implementation Outcomes: Acceptability
Time frame: 60 Days
Qualitative Implementation Outcomes: Fidelity, acceptability, feasibility, adoption
Time frame: 60 Days
Physical Activity
Time frame: 60 Days
General Health Status
Time frame: 60 Days
KCCQ12-PL Physical Limitation Score
Time frame: 60 Days
KCCQ12-SF Symptom Frequency Score
Time frame: 60 Days
KCCQ-SL Social Limitation Score
Time frame: 60 Days
Indigenous Nourishment Scale
Time frame: Baseline, 60 days
Height
Time frame: 60 days
urine albumin:creatinine
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 42507456Eberly LA, George C, Sandman S, Bex D, Jones K, Yazzie A, Gray L, Morgan L, Tennison A, Williams C, Chandra M, Wickre R, Wickre B, Bolas M, Welbel R, Ignace D, Feliciano B, Hammer S, Damon-Mallette D, Lindsey E, Mora P, Ye A, Merino M, Schisterman EF, Shin SS. An Indigenous Food Is Medicine Intervention: The MUTTON-HF Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 27:e262879. doi: 10.1001/jamainternmed.2026.2879. Online ahead of print.
- Derived from this study: PubMed 41766529Eberly LA, George C, Sandman S, Bex D, Jones K, Yazzie A, Gray L, Morgan L, Tennison A, Williams C, Chandra M, Wickre R, Wickre B, Bolas M, Welbel R, Ignace D, Feliciano B, Damon-Mallette D, Lindsey E, Mora P, Merino M, Schisterman EF, Shin SS. MUTTON-HF: Rationale and Design of a Study of an Indigenous Food is Medicine Intervention. Circ Heart Fail. 2026 Apr;19(4):e014013. doi: 10.1161/CIRCHEARTFAILURE.125.014013. Epub 2026 Mar 2.
- Study WebsiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Lauren Eberly, MD, MPH principal investigator
Indian Health Service (IHS)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored Meal Program with Traditional Navajo Foods in people with Heart Failure, run by University of Pennsylvania at 2 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization or Emergency Department Visit (time frame: 90 days). 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 NCT06549699, which also lists 2 linked publications.
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 29 Dec 2025.