Iron DeficiencyPhase 4Affirm-AHFNCT02937454
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
A Phase 4 study testing ferric carboxymaltose and Normal saline 0.9% in people with Iron Deficiency and Heart Failure, run by Vifor (International) Inc. at 16 sites in 15 countries.
Trial summary
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Heart Failure
- What is being tested?
- ferric carboxymaltose and Normal saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,132 participants
- Where
- 16 sitesin 15 countries
- Study dates
- 3 Apr 2017to 21 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation. All of the following (i.e., items a to d) must apply:
- Upon admission for the AHF episode, persistent dyspnoea at rest in a recumbent sitting position (30-45°) or with minimal exertion
- Upon or during the AHF admission, at least 2 of the following clinical findings were present: i. Congestion on chest X-ray ii. Rales on chest auscultation iii. Oedema ≥1+ on a 0-3+ scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region iv. Elevated jugular venous pressure (≥8 cm H2O)
- Natriuretic peptide levels, measured ≤72 hours of the AHF admission must have been: i. Brain natriuretic peptide (BNP) ≥400 pg/mL or N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/mL or ii. BNP ≥600 pg/mL or NT-proBNP ≥2,400 pg/mL for subjects presenting with atrial fibrillation when the blood sample was taken iii. For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation only NT-proBNP values should be considered
- AHF episode treated with minimally 40 mg of IV furosemide (or equivalent IV loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
- Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT <20%.
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- Left ventricular ejection fraction <50% (assessed and documented within 12 months prior to randomisation).
- Male or female aged ≥18 years old.
- Subject (or legally acceptable representative)* has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed.
Who cannot join
- Dyspnoea due to non-cardiac causes such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, acute bronchitis, pneumonia, primary pulmonary hypertension).
- Temperature >38°C (oral or equivalent), active infective endocarditis, sepsis, systemic inflammatory response syndrome, or any other active infection requiring anti-microbial treatment at any time during an Index hospitalisation. (Note that it does NOT include short-term prophylactic administration of antibiotics or short-term temperature elevation at admission which is no longer present at the time point of discharge/randomisation).
- Documented restricted amyloid myocardiopathy, or acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. (Note that it does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
- Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days prior randomisation.
- Severe valvular or left ventricular outflow obstruction disease needing intervention.
- Coronary-artery bypass graft, cardiac resynchronisation therapy device implantation, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic, diagnostic catheters are allowed) or major surgery that led to significant blood loss, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.
Show all 27Show fewer
- Subject has a body weight <35 kg at randomisation.
- Subject at an immediate need of transfusion or with a Hb <8 g/dL* or with a Hb >15 g/dL.
- Subjects on treatment for Vitamin B12 and/or serum folate deficiency. Note: Use of Vitamin B12 and folic acid as supplement therapy (not for deficiency treatment) is permitted.
- Subject with a known anaemia not attributed to ID (e.g., other microcytic anaemia) or with an evidence of iron overload (e.g., haemochromatosis) or disturbances in the utilisation of iron.
- Subject has known hypersensitivity to any of the study products to be administered or known serious hypersensitivity to other parenteral iron products.
- Subject with known severe allergies including drug allergies, history of severe asthma, eczema or other atopic allergy and in subjects with immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).
- History of erythropoietin stimulating agent, IV iron therapy, and/or blood transfusion in previous 3 months prior to randomisation.
- Oral iron therapy at doses >100 mg/day in previous 4 weeks prior to randomisation. Note: Ongoing use of multivitamins containing iron <75 mg/day are permitted.
- Currently receiving systemic chemotherapy and/or radiotherapy.
- Renal dialysis (previous, current or planned within the next 6 months).
- Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia.
- Terminal illness other than HF with expected survival <12 months.
- Chronic liver disease (including active hepatitis) and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.
- Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.
- Subject previously randomised into this study. Note: Subjects may be rescreened but when rescreened, all tests must fall inside the maximum specified screening windows for each criterion.
- Subject is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent(s).
- Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
- If of childbearing potential, subject is not using adequate contraceptive precautions. Subject must agree to use adequate contraception during the study and for 1 month after the last dose of study treatment. A highly effective method of birth control must be used.
- Subject has a history of drug or alcohol abuse within 2 years prior to screening.
- Subject has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator's opinion.
- Following section in italics is applicable for The Netherlands, Spain and Singapore only (NL, ES and SG only): 'The lower threshold of Hb values is set to 10 g/dL.'
Trial locations and contacts
16 sites in 15 countries.
16 sites in 15 countries
Israel2 sites
Hadassah Ein Kerem University Medical Center
Jerusalem, 91120
The Baruch Pade Medical Center
Tiberias, Lower Galilee, 15208
About this study
Official title: A Randomised, Double-Blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF)
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)
Read the detailed description
This is a randomised, double-blind, placebo-controlled Trial (RCT). The 52 weeks observation period following randomisation is considered appropriate to investigate the primary endpoint of recurrent HF hospitalisations and CV death. To evaluate the effect of intravenous ferric carboxymaltose (IV FCM) in iron deficient subjects with AHF, subjects will be enrolled during a hospital stay (Index hospitalisation) after the acute care treatment of the index event has been stabilised. All subjects will continue to receive their established standard therapy for HF and medical emergencies will be treated according to local routine.
- Conditions
- Iron Deficiency, Heart Failure
- Being tested
- ferric carboxymaltose, Normal saline 0.9%
- Keywords
- Acute Heart Failure, Iron Deficiency
- Medical subject headings
- Iron Deficiencies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric carboxymaltoseDrug
Also called Injectafer, Ferinject, Renegy, Iroprem
FCM will be administered as an undiluted bolus injection. The study treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value at the respective visits where study treatment will be administered
Normal saline 0.9%Other
Normal saline will be administered as a bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| ferric carboxymaltose | Active comparator | The first dose of study treatment will be administered for all randomised subjects while the patient is still hospitalised for the Index hospitalisation. The subsequent administrations of study treatment will be done as part of the outpatient clinic visits. Receives: Drug: ferric carboxymaltose |
| normal saline 0.9% | Placebo comparator | The first dose of study treatment will be administered for all randomised subjects on the same day as randomisation. Receives: Other: Normal saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF Hospitalizations and CV Death
HF = Heart Failure, CV = Cardiovascular.
The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization
Total hospitalisations included first and recurrent events. If a participant was hospitalised for heart failure and died within 24 h from any cardiovascular event, this was counted as one event.
Measured: up to 52 weeks after randomization
Secondary outcomes (5)
Recurrent CV Hospitalisations and CV Death
CV = Cardiovascular
The composite of recurrent CV hospitalisations and CV death at 52 weeks after randomisation
Total hospitalisations included first and recurrent events. If a participant was hospitalised for a cardiovascular reason and died within 24 h of admission from any cardiovascular event, this was counted as one event.
Measured: up to 52 weeks after randomization
HF Hospitalisations
HF = Heart Failure
HF hospitalisations up to 52 weeks after randomisation analysed as recurrent event.
Measured: up to 52 weeks after randomisation
CV Mortality
CV = Cardiovascular
CV mortality analysed as time to first event at 52 weeks after randomisation.
Measured: at 52 weeks after randomisation.
Composite of HF Hospitalisations or CV Death
HF = Heart Failure, CV = Cardiovascular
Analysed as time to first event at 52 weeks after randomisation. The number of participants with at least one HF Hospitalisation or CV Death is presented below.
Measured: at 52 weeks after randomisation
Days Lost Due to HF Hospitalisation or CV Death
HF = Heart Failure, CV = Cardiovascular
Number of days lost due to heart failure hospitalisations or cardiovascular death corresponds to the total number of days in hospital for heart failure from randomisation to last known date. Days lost due to cardiovascular death are added to the number of days lost due to heart failure hospitalisation.
Measured: at 52 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start3 Apr 2017
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor (International) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Cytel Inc.
- Responsible party
- Sponsor
- Investigators
- Piotr Ponikowski, MD, Principal investigator, Medical University Clinical Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937454
- Sponsor's protocol ID
- FER-CARS-06
- Other IDs
- 2016-001467-36, 2016
- Acronym
- Affirm-AHF
- Status last verified
- May 2021
- First submitted
- 14 Oct 2016
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosano G, Ponikowski P, Vitale C, Anker SD, Butler J, Fabien V, Filippatos G, Kirwan BA, Macdougall IC, Metra M, Ruschitzka F, Kumpeson V, Goehring UM, van der Meer P, Jankowska EA; AFFIRM-AHF investigators. Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial. Cardiovasc Diabetol. 2023 Aug 17;22(1):215. doi: 10.1186/s12933-023-01943-z.
PubMed 37592272Macdougall IC, Ponikowski P, Stack AG, Wheeler DC, Anker SD, Butler J, Filippatos G, Gohring UM, Kirwan BA, Kumpeson V, Metra M, Rosano G, Ruschitzka F, van der Meer P, Wachter S, Jankowska EA. Ferric Carboxymaltose in Iron-Deficient Patients with Hospitalized Heart Failure and Reduced Kidney Function. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1124-1134. doi: 10.2215/CJN.0000000000000223. Epub 2023 Jun 29.
PubMed 37382961Filippatos G, Ponikowski P, Farmakis D, Anker SD, Butler J, Fabien V, Kirwan BA, Macdougall IC, Metra M, Rosano G, Ruschitzka F, van der Meer P, Wachter S, Jankowska EA; AFFIRM-AHF Investigators. Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis. Circulation. 2023 May 30;147(22):1640-1653. doi: 10.1161/CIRCULATIONAHA.122.060757. Epub 2023 Apr 13.
PubMed 37051919Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.
PubMed 33197395Ponikowski P, Kirwan BA, Anker SD, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Haboubi T, Keren A, Khintibidze I, Kragten H, Martinez FA, McDonagh T, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Jankowska EA. Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure. Eur J Heart Fail. 2019 Dec;21(12):1651-1658. doi: 10.1002/ejhf.1710. Epub 2019 Dec 28.
PubMed 31883356
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF)
- ClinicalTrials.gov ID
- NCT02937454
- Acronym / sponsor ID
- Affirm-AHF / FER-CARS-06
- Conditions
- Iron Deficiency, Heart Failure
- Keywords
- Acute Heart Failure, Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,132 participants (actual)
- Lead sponsor
- Vifor (International) Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Cytel Inc.
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)
Detailed description
This is a randomised, double-blind, placebo-controlled Trial (RCT). The 52 weeks observation period following randomisation is considered appropriate to investigate the primary endpoint of recurrent HF hospitalisations and CV death. To evaluate the effect of intravenous ferric carboxymaltose (IV FCM) in iron deficient subjects with AHF, subjects will be enrolled during a hospital stay (Index hospitalisation) after the acute care treatment of the index event has been stabilised. All subjects will continue to receive their established standard therapy for HF and medical emergencies will be treated according to local routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ferric carboxymaltose | Active comparator | Drug: ferric carboxymaltoseThe first dose of study treatment will be administered for all randomised subjects while the patient is still hospitalised for the Index hospitalisation. The subsequent administrations of study treatment will be done as part of the outpatient clinic visits. |
| normal saline 0.9% | Placebo comparator | Other: Normal saline 0.9%The first dose of study treatment will be administered for all randomised subjects on the same day as randomisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation. All of the following (i.e., items a to d) must apply:
- Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT <20%.
- Left ventricular ejection fraction <50% (assessed and documented within 12 months prior to randomisation).
- Male or female aged ≥18 years old.
- Subject (or legally acceptable representative)* has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed.
Key exclusion criteria (27 listed)
- Dyspnoea due to non-cardiac causes such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, acute bronchitis, pneumonia, primary pulmonary hypertension).
- Temperature >38°C (oral or equivalent), active infective endocarditis, sepsis, systemic inflammatory response syndrome, or any other active infection requiring anti-microbial treatment at any time during an Index hospitalisation. (Note that it does NOT include short-term prophylactic administration of antibiotics or short-term temperature elevation at admission which is no longer present at the time point of discharge/randomisation).
- Documented restricted amyloid myocardiopathy, or acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. (Note that it does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
- Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days prior randomisation.
- Severe valvular or left ventricular outflow obstruction disease needing intervention.
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: Injectafer, Ferinject, Renegy, IropremFCM will be administered as an undiluted bolus injection. The study treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value at the respective visits where study treatment will be administered | Drug | ferric carboxymaltose |
| Normal saline 0.9%Normal saline will be administered as a bolus injection. | Other | normal saline 0.9% |
Primary outcome
HF Hospitalizations and CV Death
Time frame: up to 52 weeks after randomization
HF = Heart Failure, CV = Cardiovascular. The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization Total hospitalisations included first and recurrent events. If a participant was hospitalised for heart failure and died within 24 h from any cardiovascular event, this was counted as one event.
5 secondary outcomes
Recurrent CV Hospitalisations and CV Death
Time frame: up to 52 weeks after randomization
HF Hospitalisations
Time frame: up to 52 weeks after randomisation
CV Mortality
Time frame: at 52 weeks after randomisation.
Composite of HF Hospitalisations or CV Death
Time frame: at 52 weeks after randomisation
Days Lost Due to HF Hospitalisation or CV Death
Time frame: at 52 weeks after randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37592272Rosano G, Ponikowski P, Vitale C, Anker SD, Butler J, Fabien V, Filippatos G, Kirwan BA, Macdougall IC, Metra M, Ruschitzka F, Kumpeson V, Goehring UM, van der Meer P, Jankowska EA; AFFIRM-AHF investigators. Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial. Cardiovasc Diabetol. 2023 Aug 17;22(1):215. doi: 10.1186/s12933-023-01943-z.
- Derived from this study: PubMed 37382961Macdougall IC, Ponikowski P, Stack AG, Wheeler DC, Anker SD, Butler J, Filippatos G, Gohring UM, Kirwan BA, Kumpeson V, Metra M, Rosano G, Ruschitzka F, van der Meer P, Wachter S, Jankowska EA. Ferric Carboxymaltose in Iron-Deficient Patients with Hospitalized Heart Failure and Reduced Kidney Function. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1124-1134. doi: 10.2215/CJN.0000000000000223. Epub 2023 Jun 29.
- Derived from this study: PubMed 37051919Filippatos G, Ponikowski P, Farmakis D, Anker SD, Butler J, Fabien V, Kirwan BA, Macdougall IC, Metra M, Rosano G, Ruschitzka F, van der Meer P, Wachter S, Jankowska EA; AFFIRM-AHF Investigators. Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis. Circulation. 2023 May 30;147(22):1640-1653. doi: 10.1161/CIRCULATIONAHA.122.060757. Epub 2023 Apr 13.
- Derived from this study: PubMed 33197395Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.
- Derived from this study: PubMed 31883356Ponikowski P, Kirwan BA, Anker SD, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Haboubi T, Keren A, Khintibidze I, Kragten H, Martinez FA, McDonagh T, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Jankowska EA. Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure. Eur J Heart Fail. 2019 Dec;21(12):1651-1658. doi: 10.1002/ejhf.1710. Epub 2019 Dec 28.
- 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.
Piotr Ponikowski, MD principal investigator
Medical University Clinical Military Hospital
16 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ferric carboxymaltose and Normal saline 0.9% in people with Iron Deficiency and Heart Failure, run by Vifor (International) Inc. at 16 sites in 15 countries.
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 9 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: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Israel, Argentina, Brazil, Croatia, Georgia and 10 more countries. 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 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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HF Hospitalizations and CV Death (time frame: up to 52 weeks after randomization). 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 NCT02937454, which also lists 5 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 18 Jun 2021.