Heart FailurePhase 4IRONICANCT07053475
IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
A Phase 4 study testing Ferric Carboxymaltose and Ferrous Sulfate in people with Heart Failure and Heart Failure With Reduced Ejection Fraction (HFrEF), run by Syed Hamza Mufarrih at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- Ferric Carboxymaltose and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to 31 Mar 2026
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- BMI ≥18.0 kg/m²
- Hemoglobin:
- > 9 g/dL and <14 g/dL for men > 9 g/dL and <13 g/dL for women
- Diagnosed with Congestive Heart failure:
- HFrEF: EF ≤40% in any recent echocardiogram HFpEF: EF ≥50-55% without any prior EF ≤40%, and evidence of diastolic dysfunction per ASE/EACVI 2023 criteria-defined as either grade ≥2 or ≥2 supporting echo parameters (septal e' <7 cm/sec or lateral e' <10 cm/sec, E/e' ≥15, TR velocity >2.8 m/s, LA volume index ≥34 mL/m², LV septal or posterior wall thickness ≥1.2 cm, or LA area ≥20 cm² / diameter ≥3.8 cm.
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- Documented elevated NT-proBNP based on BMI and rhythm:
- BMI <35: ≥220 pg/mL (NSR) or ≥660 pg/mL (A-Fib) BMI ≥35: ≥125 pg/mL (NSR) or ≥375 pg/mL (A-Fib)
- NYHA Class II-IV
- Transferrin saturation (TSAT) <20%
- Hemoglobin <14 g/dL for men, < 13 g/dL for women.
- Stable on heart failure therapy for ≥2-4 weeks
- Currently prescribed a diuretic at home
- Ambulatory (able to walk >20 ft with minimal assistance)
- Willing and able to give informed consent
Who cannot join
- Received IV iron, ESA, or blood transfusion within the last 6-12 months
- Received high-dose oral iron (>100 mg/day in past 7 days)
- Severe renal impairment (eGFR <15 mL/min/1.73 m² or on dialysis)
- Patients with known cirrhosis or transaminitis with AST >141 or ALT >112 IU/L
- Active bleeding or known bleeding disorder
- Recent cardiac surgery, myocardial infarction, or stroke within past 3 months
Show all 12Show fewer
- Active infection, defined as any systemic or deep-seated infection (e.g., bacteremia, sepsis, osteomyelitis, or infections requiring IV antibiotics or hospitalization) at the time of screening.
- Active malignancy or undergoing chemotherapy/radiotherapy
- Vitamin B12 or folate deficiency (unless corrected prior to enrollment)
- Chronic liver disease (with LFTs >3× upper limit of normal)
- Pregnant or breastfeeding women or those not using effective contraception
- Lacks capacity to consent or unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches
The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.
The main questions the study will answer are:
Read more
- Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks?
- Does IV iron improve symptoms and quality of life more than oral iron?
- How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality?
Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.
What participants will do
- Be randomly assigned by (like flipping a coin) to IV iron or oral iron.
- Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks.
- Visit the infusion clinic at 6 weeks for second dose of IV iron if needed.
- Visit the clinic at 12 weeks for a follow-up to gather follow-up data including
- A 6-minute walk test
- Brief symptom and quality-of-life surveys
- Blood tests to measure serum iron, ferritin, and transferrin saturation
This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure With Preserved Ejection Fraction (HFPEF), Iron Deficiency, Iron-deficiency Anemia (IDA)
- Being tested
- Ferric Carboxymaltose, Ferrous Sulfate
- Keywords
- Intravenous iron, Oral iron, Ferric carboxymaltose, Ferrous sulfate, Transferrin saturation (TSAT), Functional iron deficiency, 6-minute walk test (6MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ), Quality of life, Randomized controlled trial, Congestive heart failure, HFpEF, HFrEF
- Medical subject headings
- Heart Failure, Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CarboxymaltoseDrug
Also called FCM, IV Iron
Intravenous infusion of 1 gram FCM during index hospital stay, followed by a second dose at Week 6 (1,000 mg if > 70 kg or 500 mg if ≤ 70 kg).
Ferrous SulfateDrug
Also called Ferrex, Oral Iron
Oral administration of one 150 mg capsule every 48 hours for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IV Iron (Ferric Carboxymaltose) | Experimental | Patients randomized to receive intravenous ferric carboxymaltose. Dosing includes a 1-gram IV infusion during the index hospital stay, followed by a second infusion at Week 6 (1,000 mg if > 70 kg or 500 mg if ≤ 70 kg). Receives: Drug: Ferric Carboxymaltose |
| Oral Iron (Ferrous Sulfate) | Active comparator | Patients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks. Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Distance
Change in distance (in meters) walked during the 6-minute walk test from baseline to 12 weeks.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in NYHA Functional Class
Change in New York Heart Association (NYHA) class from baseline to 12 weeks.
Measured: Baseline and 12 weeks
Change in Quality of Life
Change in patient-reported quality of life scores as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measured: Baseline and 12 weeks
Change in Iron Stores
Change in iron parameters including serum ferritin, serum iron, and transferrin saturation from baseline to 12 weeks.
Measured: Baseline and 12 weeks
All-Cause Mortality
Death from any cause during the 12-week study period.
Measured: Through 12 weeks
Heart Failure Readmissions
Number of heart failure-related hospital readmissions within 12 weeks.
Measured: Through 12 weeks
Major Adverse Cardiac Events (MACE)
Composite of cardiovascular death, myocardial infarction, or stroke during the 12-week study period.
Measured: Through 12 weeks
Adverse Events Related to Study Drug
Frequency of reported adverse effects attributed to either ferric carboxymaltose or oral ferrous sulfate during the study period.
Measured: Through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start2 Apr 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Why it stopped: Post-discharge low follow-up (\<50%) rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Randomized, 1:1, parallel-group, open-label PROBE design comparing IV ferric carboxymaltose with oral ferrous sulfate in adults with heart failure and TSAT \< 20 %.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Hamza Mufarrih
- Sponsor type
- University, hospital or other
- Collaborators
- American Regent, Inc.
- Responsible party
- Sponsor-investigator, Syed Hamza Mufarrih, Western Kentucky Heart and Lung Research Foundation and Educational Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053475
- Sponsor's protocol ID
- 24-11-18-Mufa-OralvsIV-Iron
- Other IDs
- AR2059
- Acronym
- IRONICA
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) will be made available to researchers upon reasonable request, following publication of primary results. Data sharing will require a data use agreement and IRB approval.
Publications
von Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Derad C, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Lainscak M, Butler J, Ponikowski P, Bohm M, Friede T, Anker SD. Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial. Eur Heart J. 2024 Oct 5;45(37):3789-3800. doi: 10.1093/eurheartj/ehae479.
PubMed 39185895Alcaide-Aldeano A, Garay A, Alcoberro L, Jimenez-Marrero S, Yun S, Tajes M, Garcia-Romero E, Diez-Lopez C, Gonzalez-Costello J, Mateus-Porta G, Cainzos-Achirica M, Enjuanes C, Comin-Colet J, Moliner P. Iron Deficiency: Impact on Functional Capacity and Quality of Life in Heart Failure with Preserved Ejection Fraction. J Clin Med. 2020 Apr 22;9(4):1199. doi: 10.3390/jcm9041199.
PubMed 32331365Bekfani T, Pellicori P, Morris D, Ebner N, Valentova M, Sandek A, Doehner W, Cleland JG, Lainscak M, Schulze PC, Anker SD, von Haehling S. Iron deficiency in patients with heart failure with preserved ejection fraction and its association with reduced exercise capacity, muscle strength and quality of life. Clin Res Cardiol. 2019 Feb;108(2):203-211. doi: 10.1007/s00392-018-1344-x. Epub 2018 Jul 26.
PubMed 30051186Cleland JGF, Pellicori P, Graham FJ, Lane R, Petrie MC, Ahmed F, Squire IB, Ludman A, Japp A, Al-Mohammad A, Clark AL, Szwejkowski B, Critoph C, Chong V, Schiff R, Nageh T, Glover J, McMurray JJV, Thomson EA, Robertson M, Ford I, Kalra PA, Kalra PR; IRONMAN Study Group. Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure. J Am Coll Cardiol. 2024 Oct 29;84(18):1704-1717. doi: 10.1016/j.jacc.2024.08.052.
PubMed 39443013Manceau H, Ausseil J, Masson D, Feugeas JP, Sablonniere B, Guieu R, Puy H, Peoc'h K. Neglected Comorbidity of Chronic Heart Failure: Iron Deficiency. Nutrients. 2022 Aug 5;14(15):3214. doi: 10.3390/nu14153214.
PubMed 35956390Zhou X, Xu W, Xu Y, Qian Z. Iron Supplementation Improves Cardiovascular Outcomes in Patients with Heart Failure. Am J Med. 2019 Aug;132(8):955-963. doi: 10.1016/j.amjmed.2019.02.018. Epub 2019 Mar 7.
PubMed 30853478Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
PubMed 35363499
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches
- ClinicalTrials.gov ID
- NCT07053475
- Acronym / sponsor ID
- IRONICA / 24-11-18-Mufa-OralvsIV-Iron
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure With Preserved Ejection Fraction (HFPEF), Iron Deficiency, Iron-deficiency Anemia (IDA)
- Keywords
- Intravenous iron, Oral iron, Ferric carboxymaltose, Ferrous sulfate, Transferrin saturation (TSAT), Functional iron deficiency, 6-minute walk test (6MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Post-discharge low follow-up (\<50%) rates.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Syed Hamza MufarrihUniversity, hospital or other
- Collaborators
- American Regent, Inc.
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Jul 2025 (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.
The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.
The main questions the study will answer are:
- Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks?
- Does IV iron improve symptoms and quality of life more than oral iron?
- How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality?
Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.
What participants will do
- Be randomly assigned by (like flipping a coin) to IV iron or oral iron.
- Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks.
- Visit the infusion clinic at 6 weeks for second dose of IV iron if needed.
- Visit the clinic at 12 weeks for a follow-up to gather follow-up data including
- A 6-minute walk test
- Brief symptom and quality-of-life surveys
- Blood tests to measure serum iron, ferritin, and transferrin saturation
This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, 1:1, parallel-group, open-label PROBE design comparing IV ferric carboxymaltose with oral ferrous sulfate in adults with heart failure and TSAT < 20 %.
| Arm | Type | Receives |
|---|---|---|
| IV Iron (Ferric Carboxymaltose) | Experimental | Drug: Ferric CarboxymaltosePatients randomized to receive intravenous ferric carboxymaltose. Dosing includes a 1-gram IV infusion during the index hospital stay, followed by a second infusion at Week 6 (1,000 mg if > 70 kg or 500 mg if ≤ 70 kg). |
| Oral Iron (Ferrous Sulfate) | Active comparator | Drug: Ferrous SulfatePatients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years
- BMI ≥18.0 kg/m²
- Hemoglobin:
- > 9 g/dL and <14 g/dL for men > 9 g/dL and <13 g/dL for women
- Diagnosed with Congestive Heart failure:
Key exclusion criteria (12 listed)
- Received IV iron, ESA, or blood transfusion within the last 6-12 months
- Received high-dose oral iron (>100 mg/day in past 7 days)
- Severe renal impairment (eGFR <15 mL/min/1.73 m² or on dialysis)
- Patients with known cirrhosis or transaminitis with AST >141 or ALT >112 IU/L
- Active bleeding or known bleeding disorder
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 |
|---|---|---|
| Ferric CarboxymaltoseAlso: FCM, IV IronIntravenous infusion of 1 gram FCM during index hospital stay, followed by a second dose at Week 6 (1,000 mg if > 70 kg or 500 mg if ≤ 70 kg). | Drug | IV Iron (Ferric Carboxymaltose) |
| Ferrous SulfateAlso: Ferrex, Oral IronOral administration of one 150 mg capsule every 48 hours for 12 weeks. | Drug | Oral Iron (Ferrous Sulfate) |
Primary outcome
Change in 6-Minute Walk Distance
Time frame: Baseline and 12 weeks
Change in distance (in meters) walked during the 6-minute walk test from baseline to 12 weeks.
7 secondary outcomes
Change in NYHA Functional Class
Time frame: Baseline and 12 weeks
Change in Quality of Life
Time frame: Baseline and 12 weeks
Change in Iron Stores
Time frame: Baseline and 12 weeks
All-Cause Mortality
Time frame: Through 12 weeks
Heart Failure Readmissions
Time frame: Through 12 weeks
Major Adverse Cardiac Events (MACE)
Time frame: Through 12 weeks
Adverse Events Related to Study Drug
Time frame: Through 12 weeks
Results and safety
The study was stopped early (reason given: Post-discharge low follow-up (\<50%) rates.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 39185895von Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Derad C, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Lainscak M, Butler J, Ponikowski P, Bohm M, Friede T, Anker SD. Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial. Eur Heart J. 2024 Oct 5;45(37):3789-3800. doi: 10.1093/eurheartj/ehae479.
- Results publication: PubMed 32331365Alcaide-Aldeano A, Garay A, Alcoberro L, Jimenez-Marrero S, Yun S, Tajes M, Garcia-Romero E, Diez-Lopez C, Gonzalez-Costello J, Mateus-Porta G, Cainzos-Achirica M, Enjuanes C, Comin-Colet J, Moliner P. Iron Deficiency: Impact on Functional Capacity and Quality of Life in Heart Failure with Preserved Ejection Fraction. J Clin Med. 2020 Apr 22;9(4):1199. doi: 10.3390/jcm9041199.
- Results publication: PubMed 30051186Bekfani T, Pellicori P, Morris D, Ebner N, Valentova M, Sandek A, Doehner W, Cleland JG, Lainscak M, Schulze PC, Anker SD, von Haehling S. Iron deficiency in patients with heart failure with preserved ejection fraction and its association with reduced exercise capacity, muscle strength and quality of life. Clin Res Cardiol. 2019 Feb;108(2):203-211. doi: 10.1007/s00392-018-1344-x. Epub 2018 Jul 26.
- Results publication: PubMed 39443013Cleland JGF, Pellicori P, Graham FJ, Lane R, Petrie MC, Ahmed F, Squire IB, Ludman A, Japp A, Al-Mohammad A, Clark AL, Szwejkowski B, Critoph C, Chong V, Schiff R, Nageh T, Glover J, McMurray JJV, Thomson EA, Robertson M, Ford I, Kalra PA, Kalra PR; IRONMAN Study Group. Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure. J Am Coll Cardiol. 2024 Oct 29;84(18):1704-1717. doi: 10.1016/j.jacc.2024.08.052.
- Results publication: PubMed 35956390Manceau H, Ausseil J, Masson D, Feugeas JP, Sablonniere B, Guieu R, Puy H, Peoc'h K. Neglected Comorbidity of Chronic Heart Failure: Iron Deficiency. Nutrients. 2022 Aug 5;14(15):3214. doi: 10.3390/nu14153214.
- Results publication: PubMed 30853478Zhou X, Xu W, Xu Y, Qian Z. Iron Supplementation Improves Cardiovascular Outcomes in Patients with Heart Failure. Am J Med. 2019 Aug;132(8):955-963. doi: 10.1016/j.amjmed.2019.02.018. Epub 2019 Mar 7.
- Results publication: PubMed 35363499Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) will be made available to researchers upon reasonable request, following publication of primary results. Data sharing will require a data use agreement and IRB approval.
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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.
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 Ferric Carboxymaltose and Ferrous Sulfate in people with Heart Failure and Heart Failure With Reduced Ejection Fraction (HFrEF), run by Syed Hamza Mufarrih 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 15 inclusion and 12 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 20 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: Post-discharge low follow-up (\<50%) rates.). 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?
Change in 6-Minute Walk Distance (time frame: Baseline and 12 weeks). 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 NCT07053475, which also lists 7 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 20 Jul 2026.