Iron-deficiencyPhase 4FAIR-HFpEFNCT03074591
Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction
A Phase 4 study testing Ferric Carboxymaltose 50Mg/Ml Inj 15Ml and Saline Solution for Injection in people with Iron-deficiency and Heart Failure, run by Charite University, Berlin, Germany at 7 sites in Germany.
Trial summary
This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe 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 50Mg/Ml Inj 15Ml and Saline Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 7 sitesGermany
- Study dates
- 1 Aug 2017to 10 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing to participate and provides written informed consent;
- Age ≥18 years;
- Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF ≥45% at screening or within 6 months prior to planned randomisation (assessed by echocardiography or MRI);
- Ambulatory for at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a hospitalisation);
- Treated with a diuretic;
- Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients (calculated per centre);
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- At screening or randomisation, presence of one of the following criteria:
- hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
- raised plasma levels of natriuretic peptides in a patient with sinus rhythm (i.e. in patients without AF: NT-proBNP >300 pg/mL or BNP >100 pg/mL or MR-proANP >120 pmol/L; in patients with AF: NT-proBNP >600 pg/mL or BNP >200 pg/mL or MR-proANP >250 pmol/l)
- Evidence of diastolic dysfunction at screening or randomisation, defined as:
- E/E' >13; OR
- LA width ≥38 mm; OR
- LA length ≥50 mm; OR
- LA area ≥20 cm2; OR
- LA volume ≥55 ml; OR
- left atrial volume index >28 mL/m2;
- Haemoglobin >9.0 g/dL and ≤14.0 g/dL (at screening);
- ID with ferritin <100 ng/mL or ferritin 100-299 plus TSAT <20% (at screening);
- 6-minute-walking distance at baseline <450 m (average of the last 2 documented tests within 8 weeks prior to planned randomisation that also need to be within 20% of each other).
Who cannot join
- Unable to sign informed consent
- Any prior echocardiography measurement of LVEF <40%;
- Clinical signs and symptoms of infection including fever >38°C;
- Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
- Use of concurrent immunosuppressive therapy;
- History of acquired iron overload or haemochromatosis (or a first relative with haemochromatosis);
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- Known hypersensitivity to FCM or any other IV iron product;
- Known bleeding or haemolytic anemia;
- Presence of any condition that precludes exercise testing, such as decompensated HF, significant musculoskeletal disease, unstable angina pectoris, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled brady-arrhythmias or tachy-arrhythmias;
- Probable alternative diagnoses that in the opiniton of the investigator could account for the patient's HF symptoms such as severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD); hence, patients with the following are excluded:
- Severe COPD, i.e. with known FEV1 <50%, requiring home oxygen therapy, or on chronic oral steroid therapy;
- body mass index ≥40.0 kg/m2;
- Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
- Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
- Renal replacement therapy;
- Concurrent therapy with an erythropoiesis stimulating agent;
- Known active malignancy;
- Known HIV or active hepatitis infection;
- Pregnancy;
- Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
- Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial.
- Participation in another clinical trial within previous 30 days and/ or anticipated participation in another trial during this study.
- Inability to fully comprehend and/or perform study procedures in the investigator's opinion;
- Persons staying at an institution due to order by a national body or a court of law.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Charité University Medicine Berlin
Berlin, 13353
Herzzentrum Dresden GmbH
Dresden, Saxony, 01307
University Medical Center Göttingen
Göttingen, Lower Saxony, 37075
Universitäres Herzzentrum Hamburg
Hamburg, 20095
Saarland University Medical Center
Homburg, Saarland, 66421
Innere Medizin/Kardiologie
Nuremberg, Bavaria, 90402
Herzklinik Ulm
Ulm, 89077
About this study
Official title: Effect of IV Iron (Ferric Carboxymaltose, Ferinject) on Exercise Tolerance, Symptoms and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) and Iron Deficiency With and Without Anaemia.
This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe
Read the detailed description
All previous trials have excluded patients with HFpEF. This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe. The FAIR-HFpEF study was designed to evaluate the efficacy of Ferinject® in improving symptoms of HFpEF in patients with ID. Analyses will focus both on subjective and objective measures as well as on patients with and without anaemia. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
- Conditions
- Iron-deficiency, Heart Failure
- Being tested
- Ferric Carboxymaltose 50Mg/Ml Inj 15Ml, Saline Solution for Injection
- Keywords
- Iron deficiency, Heart failure
- Medical subject headings
- Anemia, Iron-Deficiency, Heart Failure, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose 50Mg/Ml Inj 15MlDrug
Also called Ferric Carboxymaltose
After baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule.
Saline Solution for InjectionDrug
Also called Saline Solution
In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Active treatment: Ferric Carboxymaltose solution (Ferinject®) for parenteral application, 50 mg/mL iron. Medication will be given as a short time infusion over 15 minutes in 100mL NaCl. Receives: Drug: Ferric Carboxymaltose 50Mg/Ml Inj 15Ml |
| Placebo | Placebo comparator | Placebo: Normal saline (0.9% weight/volume (w/v) NaCl) administered in analogy to active treatment procedures. Receives: Drug: Saline Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
The difference of 6-minute walking distance in meters from baseline to week 24 in symptomatic patients with HFpEF with documented ID compared to the control group.
Measured: 24 weeks
Secondary outcomes (5)
6min-walking distance
Difference in 6-minute walking distance in meters from baseline to end of study in symptomatic patients with HFpEF with documented ID compared to the control group
Measured: 52 weeks
Patient Global Assessment (PGA)
Difference in Patient Global Assessment (PGA) in symptomatic patients with HFpEF with documented ID from baseline to end of study.
(7-point Likert scale [non-parametric])
Measured: 52 weeks
NYHA functional class
Difference in NYHA class from baseline to end of study in symptomatic patients with HFpEF
Measured: 52 weeks
Change in quality of life assessments
Difference in quality of life assessments (EQ-5D (= European Quality of Life 5 Dimensions 3 Level Version; = tool for Patient-Reported Outcomes (PRO) measurement); KCCQ (= Kansas City Cardiomyopathy Questionnaire)) from baseline to end of study in symptomatic patients with HFpEF.
KCCQ: (0-100) -> 100=best
EQ-5D (5-point Likert scale, 5 dimensions (mobility, self-care, usual activities, pain, anxiety) 5 levels (1 = no problems level 5 = extreme problems))
Measured: 52 weeks
Rate of recurrent heart failure hospitalisations and death
Difference in the rate of recurrent heart failure hospitalisations and deaths in symptomatic patients with HFpEF and ID.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Aug 2017
- Primary completion13 Dec 2022
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Göttingen
- Responsible party
- Principal investigator, Prof. Stefan D Anker, Charite University, Berlin, Germany
- Investigators
- Stefan Anker, Prof, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074591
- Sponsor's protocol ID
- Charite
- Acronym
- FAIR-HFpEF
- Status last verified
- May 2024
- First submitted
- 1 Mar 2017
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Publications
von Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Ponikowski P, Böhm M, Friede T, Anker SD. Iron deficiency in heart failure with preserved ejecton fracton: ratonale and design of the FAIR-HFpEF trial. Global Cardiol 2023; 1: 39-46.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IV Iron (Ferric Carboxymaltose, Ferinject) on Exercise Tolerance, Symptoms and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) and Iron Deficiency With and Without Anaemia.
- ClinicalTrials.gov ID
- NCT03074591
- Acronym / sponsor ID
- FAIR-HFpEF / Charite
- Conditions
- Iron-deficiency, Heart Failure
- Keywords
- Iron deficiency, Heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Göttingen
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 9 Mar 2017 (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.
This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe
Detailed description
All previous trials have excluded patients with HFpEF. This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe. The FAIR-HFpEF study was designed to evaluate the efficacy of Ferinject® in improving symptoms of HFpEF in patients with ID. Analyses will focus both on subjective and objective measures as well as on patients with and without anaemia. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Ferric Carboxymaltose 50Mg/Ml Inj 15MlActive treatment: Ferric Carboxymaltose solution (Ferinject®) for parenteral application, 50 mg/mL iron. Medication will be given as a short time infusion over 15 minutes in 100mL NaCl. |
| Placebo | Placebo comparator | Drug: Saline Solution for InjectionPlacebo: Normal saline (0.9% weight/volume (w/v) NaCl) administered in analogy to active treatment procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient is willing to participate and provides written informed consent;
- Age ≥18 years;
- Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF ≥45% at screening or within 6 months prior to planned randomisation (assessed by echocardiography or MRI);
- Ambulatory for at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a hospitalisation);
- Treated with a diuretic;
Key exclusion criteria (24 listed)
- Unable to sign informed consent
- Any prior echocardiography measurement of LVEF <40%;
- Clinical signs and symptoms of infection including fever >38°C;
- Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
- Use of concurrent immunosuppressive therapy;
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 Carboxymaltose 50Mg/Ml Inj 15MlAlso: Ferric CarboxymaltoseAfter baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule. | Drug | Treatment |
| Saline Solution for InjectionAlso: Saline SolutionIn the placebo/saline group, patients will receive the aequivalent number of normal saline infusions. | Drug | Placebo |
Primary outcome
exercise capacity
Time frame: 24 weeks
The difference of 6-minute walking distance in meters from baseline to week 24 in symptomatic patients with HFpEF with documented ID compared to the control group.
5 secondary outcomes
6min-walking distance
Time frame: 52 weeks
Patient Global Assessment (PGA)
Time frame: 52 weeks
NYHA functional class
Time frame: 52 weeks
Change in quality of life assessments
Time frame: 52 weeks
Rate of recurrent heart failure hospitalisations and death
Time frame: 52 weeks
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 31 May 2024.
- Backgroundvon Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Ponikowski P, Böhm M, Friede T, Anker SD. Iron deficiency in heart failure with preserved ejecton fracton: ratonale and design of the FAIR-HFpEF trial. Global Cardiol 2023; 1: 39-46.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. upon reasonable request
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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.
Stefan Anker, Prof principal investigator
Charite University, Berlin, Germany
7 sites 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 50Mg/Ml Inj 15Ml and Saline Solution for Injection in people with Iron-deficiency and Heart Failure, run by Charite University, Berlin, Germany at 7 sites in Germany.
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 19 inclusion and 24 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 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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?
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?
exercise capacity (time frame: 24 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 NCT03074591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.