Heart FailurePhase 4NCT05816265
Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure
A Phase 4 study testing IV Iron Infusion Group in people with Heart Failure and Iron-deficiency, run by Radha Gopalan at 1 site in United States.
Trial summary
Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Iron-deficiency
- What is being tested?
- IV Iron Infusion Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 18 Nov 2025
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90 years
- New York Heart Association Class II-III heart failure
- Left ventricular dysfunction with left ventricular ejection fraction ≤ 40%
- Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%
- Patients deemed by an attending physician to require intravenous iron therapy
- The patient is willing and able to comply with the protocol and has provided written informed consent
Who cannot join
- Iron overload disorders or allergy, concomitant nutritional deficiencies- B12 and folate
- Recent Acute Coronary Syndrome
- Physical barriers to exercise capacity
- Currently presenting in heart failure exacerbation
- Declined participation
- Chronic liver disease
Show all 10Show fewer
- NYHA class IV
- Active bleeding
- Pregnancy
- Life expectancy ≤ 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, 85006
About this study
Official title: Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure With Reduced Ejection Fraction and Iron Deficiency
Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake.
Read the detailed description
Currently 5.7 million people in the United States (US) have Heart Failure and it is expected that by 2030 more than 8 million people will have this condition, accounting for a 46 % increase in prevalence. Iron deficiency and anemia are both common findings in patients with heart failure and contribute to morbidity and mortality. The average cost of hospital admissions for heart failure are about $17,000-25,000; creating a large burden on health-care resources and iron replacement may serve to reduce readmissions at less than a tenth of the cost.
The working hypothesis to support Iron supplementation is that it improves oxygen carrying capacity, thereby improving exercise tolerance. Exercise tolerance in patients with heart failure is an important prognostic indicator.
Role of iron supplementation has been investigated to improve quality of life and outcomes in patients with heart failure and two large multi-centric trails. FAIR-HF and CONFIRM-HF have both showed significant improvement in symptoms and six-minute walk distances in patients with HFrEF after IV iron supplementation. This was found to be true for both anemic and non-anemic patients. Despite the current data, IV iron supplementation is currently only a class IIb recommendation for HFrEF and routine testing of iron studies, is not a part of practice guidelines for heart failure management.
Part of what makes the existing data less compelling is that exercise tolerance was assessed using a 6-minute walk test and though it correlates with functional capacity, it is a sub-maximal exercise test and cannot assess the peak oxygen uptake. Individuals with heart failure are often unable to attain this peak oxygen uptake. The inability to increase O2 uptake with exercise is what affects exercise capacity.
The study aims to bridge the gap between the response seen after IV iron supplementation and the change in physiology we attribute to it using a formal Cardiopulmonary exercise testing. A peak VO2 provides the most objective assessment of functional capacity in patients with HF. This parameter is a surrogate marker for the maximal cardiac output that an individual can achieve. A modest increase in peak VO2 of 6% at 3 months of exercise training has been associated with a reduction in mortality by 5 %.
- Conditions
- Heart Failure, Iron-deficiency
- Being tested
- IV Iron Infusion Group
- Keywords
- Reduced ejection fraction, Exercise, iron supplementation, Cardiopulmonary exercise, peak oxygen uptake
- Medical subject headings
- Heart Failure, Anemia, Iron-Deficiency, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Iron Infusion GroupDrug
Also called Ferric carboxymaltose injection
Subjects will receive IV Iron Infusion. Dosage of iron will be at discretion of physicians
| Study group | Role | What they receive |
|---|---|---|
| IV Iron Infusion Group | Experimental | Subjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians Receives: Drug: IV Iron Infusion Group |
| Control Group | No intervention | Subjects will not receive iron replacement infusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Cardiopulmonary exercise testing will be administered to measure Peak V02. During the exercise testing a special mouthpiece that can measure oxygen and carbon dioxide is used to measure peak oxygen uptake.
Measured: 2 months after IV iron infusion
Patient subjective outcome measures
Subjects will complete the Kansas City Cardiomyopathy Questionnaire.The lowest score is 0 and the highest score is 100. The higher the score is, the better the quality of life.
Measured: 2 months after IV iron infusion
Secondary outcomes (1)
Objective Quality of Life measures
A 6-minute walk test will be administered to determine if the NYHA class has improved.
Measured: 2 months after IV iron infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start24 Jan 2024
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Why it stopped: Difficulty with accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be 1:1 between control group and iron group. Subjects randomized to the iron group will receive iron infusion 1 week after enrollment. The control group will not receive iron replacement infusion.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radha Gopalan
- Sponsor type
- University, hospital or other
- Collaborators
- American Regent, Inc.
- Responsible party
- Sponsor-investigator, Radha Gopalan, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816265
- Sponsor's protocol ID
- STUDY00001297
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only coded research data will be shared for data analysis by study team. Only limited data set may be shared with sponsor if requested according to data agreement. Future use data will be de-identified and stored in REDCap and only utilized by the investigator's department researchers. Publications and reports will be de-identified.
Publications
Jankowska EA, Rozentryt P, Witkowska A, Nowak J, Hartmann O, Ponikowska B, Borodulin-Nadzieja L, Banasiak W, Polonski L, Filippatos G, McMurray JJ, Anker SD, Ponikowski P. Iron deficiency: an ominous sign in patients with systolic chronic heart failure. Eur Heart J. 2010 Aug;31(15):1872-80. doi: 10.1093/eurheartj/ehq158. Epub 2010 Jun 21.
PubMed 20570952von Haehling S, Ebner N, Evertz R, Ponikowski P, Anker SD. Iron Deficiency in Heart Failure: An Overview. JACC Heart Fail. 2019 Jan;7(1):36-46. doi: 10.1016/j.jchf.2018.07.015. Epub 2018 Dec 12.
PubMed 30553903Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013 Sep 23;5(9):3730-9. doi: 10.3390/nu5093730.
PubMed 24064572Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
PubMed 19920054Ezekowitz JA, McAlister FA, Armstrong PW. Anemia is common in heart failure and is associated with poor outcomes: insights from a cohort of 12 065 patients with new-onset heart failure. Circulation. 2003 Jan 21;107(2):223-5. doi: 10.1161/01.cir.0000052622.51963.fc.
PubMed 12538418Klip IT, Comin-Colet J, Voors AA, Ponikowski P, Enjuanes C, Banasiak W, Lok DJ, Rosentryt P, Torrens A, Polonski L, van Veldhuisen DJ, van der Meer P, Jankowska EA. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013 Apr;165(4):575-582.e3. doi: 10.1016/j.ahj.2013.01.017. Epub 2013 Feb 22.
PubMed 23537975Okonko DO, Mandal AK, Missouris CG, Poole-Wilson PA. Disordered iron homeostasis in chronic heart failure: prevalence, predictors, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol. 2011 Sep 13;58(12):1241-51. doi: 10.1016/j.jacc.2011.04.040.
PubMed 21903058Lim EA, Sohn HS, Lee H, Choi SE. Cost-utility of ferric carboxymaltose (Ferinject(R)) for iron-deficiency anemia patients with chronic heart failure in South Korea. Cost Eff Resour Alloc. 2014 Sep 10;12:19. doi: 10.1186/1478-7547-12-19. eCollection 2014.
PubMed 25278814Wang G, Zhang Z, Ayala C, Wall HK, Fang J. Costs of heart failure-related hospitalizations in patients aged 18 to 64 years. Am J Manag Care. 2010 Oct;16(10):769-76.
PubMed 20964473Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.
PubMed 18672162Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.
PubMed 22773109
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure With Reduced Ejection Fraction and Iron Deficiency
- ClinicalTrials.gov ID
- NCT05816265
- Acronym / sponsor ID
- STUDY00001297
- Conditions
- Heart Failure, Iron-deficiency
- Keywords
- Reduced ejection fraction, Exercise, iron supplementation, Cardiopulmonary exercise, peak oxygen uptake
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Radha GopalanUniversity, hospital or other
- Collaborators
- American Regent, Inc.
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 18 Apr 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.
Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake.
Detailed description
Currently 5.7 million people in the United States (US) have Heart Failure and it is expected that by 2030 more than 8 million people will have this condition, accounting for a 46 % increase in prevalence. Iron deficiency and anemia are both common findings in patients with heart failure and contribute to morbidity and mortality. The average cost of hospital admissions for heart failure are about $17,000-25,000; creating a large burden on health-care resources and iron replacement may serve to reduce readmissions at less than a tenth of the cost.
The working hypothesis to support Iron supplementation is that it improves oxygen carrying capacity, thereby improving exercise tolerance. Exercise tolerance in patients with heart failure is an important prognostic indicator.
Role of iron supplementation has been investigated to improve quality of life and outcomes in patients with heart failure and two large multi-centric trails. FAIR-HF and CONFIRM-HF have both showed significant improvement in symptoms and six-minute walk distances in patients with HFrEF after IV iron supplementation. This was found to be true for both anemic and non-anemic patients. Despite the current data, IV iron supplementation is currently only a class IIb recommendation for HFrEF and routine testing of iron studies, is not a part of practice guidelines for heart failure management.
Part of what makes the existing data less compelling is that exercise tolerance was assessed using a 6-minute walk test and though it correlates with functional capacity, it is a sub-maximal exercise test and cannot assess the peak oxygen uptake. Individuals with heart failure are often unable to attain this peak oxygen uptake. The inability to increase O2 uptake with exercise is what affects exercise capacity.
The study aims to bridge the gap between the response seen after IV iron supplementation and the change in physiology we attribute to it using a formal Cardiopulmonary exercise testing. A peak VO2 provides the most objective assessment of functional capacity in patients with HF. This parameter is a surrogate marker for the maximal cardiac output that an individual can achieve. A modest increase in peak VO2 of 6% at 3 months of exercise training has been associated with a reduction in mortality by 5 %.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be 1:1 between control group and iron group. Subjects randomized to the iron group will receive iron infusion 1 week after enrollment. The control group will not receive iron replacement infusion.
| Arm | Type | Receives |
|---|---|---|
| IV Iron Infusion Group | Experimental | Drug: IV Iron Infusion GroupSubjects will receive iron infusion 1 week after enrollment. Dosage of iron will be at discretion of physicians |
| Control Group | No intervention | –Subjects will not receive iron replacement infusion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-90 years
- New York Heart Association Class II-III heart failure
- Left ventricular dysfunction with left ventricular ejection fraction ≤ 40%
- Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%
- Patients deemed by an attending physician to require intravenous iron therapy
Key exclusion criteria (10 listed)
- Iron overload disorders or allergy, concomitant nutritional deficiencies- B12 and folate
- Recent Acute Coronary Syndrome
- Physical barriers to exercise capacity
- Currently presenting in heart failure exacerbation
- Declined participation
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 |
|---|---|---|
| IV Iron Infusion GroupAlso: Ferric carboxymaltose injectionSubjects will receive IV Iron Infusion. Dosage of iron will be at discretion of physicians | Drug | IV Iron Infusion Group |
Primary outcome
Exercise Capacity
Time frame: 2 months after IV iron infusion
Cardiopulmonary exercise testing will be administered to measure Peak V02. During the exercise testing a special mouthpiece that can measure oxygen and carbon dioxide is used to measure peak oxygen uptake.
Patient subjective outcome measures
Time frame: 2 months after IV iron infusion
Subjects will complete the Kansas City Cardiomyopathy Questionnaire.The lowest score is 0 and the highest score is 100. The higher the score is, the better the quality of life.
1 secondary outcome
Objective Quality of Life measures
Time frame: 2 months after IV iron infusion
Results and safety
The study was stopped early (reason given: Difficulty with accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 20570952Jankowska EA, Rozentryt P, Witkowska A, Nowak J, Hartmann O, Ponikowska B, Borodulin-Nadzieja L, Banasiak W, Polonski L, Filippatos G, McMurray JJ, Anker SD, Ponikowski P. Iron deficiency: an ominous sign in patients with systolic chronic heart failure. Eur Heart J. 2010 Aug;31(15):1872-80. doi: 10.1093/eurheartj/ehq158. Epub 2010 Jun 21.
- Background: PubMed 30553903von Haehling S, Ebner N, Evertz R, Ponikowski P, Anker SD. Iron Deficiency in Heart Failure: An Overview. JACC Heart Fail. 2019 Jan;7(1):36-46. doi: 10.1016/j.jchf.2018.07.015. Epub 2018 Dec 12.
- Background: PubMed 24064572Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013 Sep 23;5(9):3730-9. doi: 10.3390/nu5093730.
- Background: PubMed 19920054Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
- Background: PubMed 12538418Ezekowitz JA, McAlister FA, Armstrong PW. Anemia is common in heart failure and is associated with poor outcomes: insights from a cohort of 12 065 patients with new-onset heart failure. Circulation. 2003 Jan 21;107(2):223-5. doi: 10.1161/01.cir.0000052622.51963.fc.
- Background: PubMed 23537975Klip IT, Comin-Colet J, Voors AA, Ponikowski P, Enjuanes C, Banasiak W, Lok DJ, Rosentryt P, Torrens A, Polonski L, van Veldhuisen DJ, van der Meer P, Jankowska EA. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013 Apr;165(4):575-582.e3. doi: 10.1016/j.ahj.2013.01.017. Epub 2013 Feb 22.
- Background: PubMed 21903058Okonko DO, Mandal AK, Missouris CG, Poole-Wilson PA. Disordered iron homeostasis in chronic heart failure: prevalence, predictors, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol. 2011 Sep 13;58(12):1241-51. doi: 10.1016/j.jacc.2011.04.040.
- Background: PubMed 25278814Lim EA, Sohn HS, Lee H, Choi SE. Cost-utility of ferric carboxymaltose (Ferinject(R)) for iron-deficiency anemia patients with chronic heart failure in South Korea. Cost Eff Resour Alloc. 2014 Sep 10;12:19. doi: 10.1186/1478-7547-12-19. eCollection 2014.
- Background: PubMed 20964473Wang G, Zhang Z, Ayala C, Wall HK, Fang J. Costs of heart failure-related hospitalizations in patients aged 18 to 64 years. Am J Manag Care. 2010 Oct;16(10):769-76.
- Background: PubMed 18672162Fang J, Mensah GA, Croft JB, Keenan NL. Heart failure-related hospitalization in the U.S., 1979 to 2004. J Am Coll Cardiol. 2008 Aug 5;52(6):428-34. doi: 10.1016/j.jacc.2008.03.061.
- Background: PubMed 22773109Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.
- Individual participant dataSharing planned: No. Only coded research data will be shared for data analysis by study team. Only limited data set may be shared with sponsor if requested according to data agreement. Future use data will be de-identified and stored in REDCap and only utilized by the investigator's department researchers. Publications and reports will be de-identified.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Iron Infusion Group in people with Heart Failure and Iron-deficiency, run by Radha Gopalan at 1 site 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 10 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: stopped early, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with accrual.). Results are not available in the source record.
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?
Exercise Capacity (time frame: 2 months after IV iron infusion). The study lists 2 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 NCT05816265, which also lists 11 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 Jul 2026.