Iron-deficiencyPhase 2NCT03218384
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
A Phase 2 study testing Ferric Carboxymaltose and 31P MRS/MRI in people with Iron-deficiency, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF). Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Ferric Carboxymaltose and 31P MRS/MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 4 Apr 2022
- Phase
- Phase 2
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic NYHA Class II-III heart failure >3 months
- Guideline-recommended heart failure treatment for > 3 months
- Hemoglobin >13 g/dl for men and >12 g/dl for women
- Functional iron deficiency (defined as serum ferritin level <100 ng/ml or between 100 and 299 ng/ml with transferrin saturation <20%)
- Left ventricular ejection fraction <40%, or left ventricular ejection fraction ≥40% with left atrial enlargement (left atrial volume index >28 ml/m2) and/or left ventricular hypertrophy (left ventricular mass index >95 g/m2 (women) or >115 g/m2 (men) determined by echocardiogram within last 24 months.
- Able and willing to provide written informed consent
Who cannot join
- Presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
- Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy
- Weight <50 kg or >120 kg
- Coronary or cerebral atherothrombotic events in the past 6 months
- Hospitalization of emergency room visit for heart failure within past 3 months
- ICD shock in last 3 months
Show all 21Show fewer
- Known peripheral artery disease or ankle-brachial index <0.9 at screening visit
- Exercise primarily limited by angina, lung disease or neuromuscular disease
- Systolic blood pressure <100 or >160 mmHg
- Heart rate <50 or >110 min-1
- Estimated glomerular filtration rate <30 ml/min
- Liver function tests >3 times upper limit of normal
- Serum phosphate below normal limit
- Pregnant or breast-feeding women
- Women of child-bearing potential unwilling to use recommended contraception methods during the study
- Treatment with oral iron supplements (except multivitamins) in past year
- Treatment with intravenous iron in past year
- Treatment with erythropoiesis stimulating agents in the past year
- Known intolerance of intravenous iron
- History of anaphylaxis
- Participation in another clinical trial within last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF).
Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low body levels of iron might increase shortness of breath and fatigue.
Read the detailed description
The purpose of this prospective, double blind parallel group randomized study is to compare the effects of ferric carboxymaltose vs. placebo on skeletal muscle mitochondrial oxidative capacity, submaximal exercise tolerance, and health-related quality of life in non-anemic Heart Failure (HF) patients with functional iron deficiency.
- Conditions
- Iron-deficiency
- Being tested
- Ferric Carboxymaltose, Placebo, 31P MRS/MRI
- Keywords
- Injectafer, ferric carboxymaltose, Supplemental Iron
- Medical subject headings
- 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 Injectafer
Intravenous Ferric Carboxymaltose 750 mg mixed under sterile conditions in 100 ml of normal saline for final concentration of 7.5 mg/ml and administered via volumetric infusion pump over 15 minutes.
PlaceboDrug
Also called Saline
100 ml of normal saline solution, and administered via volumetric infusion pump over 15 minutes.
31P MRS/MRIDevice
Also called 3T Siemens MRI
Each participant will perform the same rhythmic plantar extension exercise protocol twice, for sequential acquisition of magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) measurements. For the exercise protocol, the participant will lay supine on the scanning table with the right leg inside the volume coil. The exercise consists of repeated plantar flexion movements using resistance bands at a frequency of one repetition per second for 1-2 minutes. Data are collected continuously for 2 minutes before the exercise (baseline), during exercise, and 5 minutes after the exercise for the MRS and MRI experiments.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose | Experimental | HF patients with functional iron deficiency assigned to receive one-time dose of Ferric Carboxymaltose 750 mg. Participants will undergo serial assessment before and 4 weeks after study drug administration Receives: Drug: Ferric Carboxymaltose; Device: 31P MRS/MRI |
| Placebo | Active comparator | HF patients with functional iron deficiency assigned to receive one-time dose of Placebo (saline injection). Participants will undergo serial assessment before and 4 weeks after study drug administration. Receives: Drug: Placebo; Device: 31P MRS/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
Post-exercise phosphocreatine recovery time (in seconds) will be used to assess mitochondrial oxidative capacity. It is measured non-invasively with 31P-magnetic resonance spectroscopy.
Measured: Baseline, Week 4
Secondary outcomes (5)
Change From Baseline in 6-Minute Walk Test Distance
The 6-minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
Measured: Baseline, Week 4
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score
23-item self-assessment of symptoms, physical and social limitations, and quality of life in patients with heart failure. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best. The total score ranges from 0-100, with higher scores indicating better health status. An increase in scores indicates health status improved during the observational period.
Measured: Baseline, Week 4
Change From Baseline in Hemoglobin Levels
Hemoglobin is a protein in red blood cells that carries oxygen. Hemoglobin levels (g/dL) were measured in laboratory analyses using patient blood samples.
Measured: Baseline, Week 4
Change From Baseline in Serum Ferritin Levels
Ferritin is a blood protein that contains iron. Serum ferritin levels (ng/ml) were measured in laboratory analyses using patient blood samples.
Measured: Baseline, Week 4
Change From Baseline in Transferrin Saturation
Transferrin saturation, measured as a percentage, is the value of serum iron divided by the total iron-binding capacity of the available transferrin. Transferrin saturation was measured in laboratory analyses using patient blood samples.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start7 Sep 2017
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Why it stopped: Unable to complete enrollment as planned.
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.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Katz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218384
- Sponsor's protocol ID
- 17-00444
- Status last verified
- Jun 2023
- First submitted
- 12 Jul 2017
- Last updated
- 5 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
- ClinicalTrials.gov ID
- NCT03218384
- Acronym / sponsor ID
- 17-00444
- Conditions
- Iron-deficiency
- Keywords
- Injectafer, ferric carboxymaltose, Supplemental Iron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete enrollment as planned.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Posted 5 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF).
Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low body levels of iron might increase shortness of breath and fatigue.
Detailed description
The purpose of this prospective, double blind parallel group randomized study is to compare the effects of ferric carboxymaltose vs. placebo on skeletal muscle mitochondrial oxidative capacity, submaximal exercise tolerance, and health-related quality of life in non-anemic Heart Failure (HF) patients with functional iron deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose | Experimental | Drug: Ferric Carboxymaltose, Device: 31P MRS/MRIHF patients with functional iron deficiency assigned to receive one-time dose of Ferric Carboxymaltose 750 mg. Participants will undergo serial assessment before and 4 weeks after study drug administration |
| Placebo | Active comparator | Drug: Placebo, Device: 31P MRS/MRIHF patients with functional iron deficiency assigned to receive one-time dose of Placebo (saline injection). Participants will undergo serial assessment before and 4 weeks after study drug administration. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptomatic NYHA Class II-III heart failure >3 months
- Guideline-recommended heart failure treatment for > 3 months
- Hemoglobin >13 g/dl for men and >12 g/dl for women
- Functional iron deficiency (defined as serum ferritin level <100 ng/ml or between 100 and 299 ng/ml with transferrin saturation <20%)
- Left ventricular ejection fraction <40%, or left ventricular ejection fraction ≥40% with left atrial enlargement (left atrial volume index >28 ml/m2) and/or left ventricular hypertrophy (left ventricular mass index >95 g/m2 (women) or >115 g/m2 (men) determined by echocardiogram within last 24 months.
Key exclusion criteria (21 listed)
- Presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
- Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy
- Weight <50 kg or >120 kg
- Coronary or cerebral atherothrombotic events in the past 6 months
- Hospitalization of emergency room visit for heart failure within past 3 months
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: InjectaferIntravenous Ferric Carboxymaltose 750 mg mixed under sterile conditions in 100 ml of normal saline for final concentration of 7.5 mg/ml and administered via volumetric infusion pump over 15 minutes. | Drug | Ferric Carboxymaltose |
| PlaceboAlso: Saline100 ml of normal saline solution, and administered via volumetric infusion pump over 15 minutes. | Drug | Placebo |
| 31P MRS/MRIAlso: 3T Siemens MRIEach participant will perform the same rhythmic plantar extension exercise protocol twice, for sequential acquisition of magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) measurements. For the exercise protocol, the participant will lay supine on the scanning table with the right leg inside the volume coil. The exercise consists of repeated plantar flexion movements using resistance bands at a frequency of one repetition per second for 1-2 minutes. Data are collected continuously for 2 minutes before the exercise (baseline), during exercise, and 5 minutes after the exercise for the MRS and MRI experiments. | Device | Ferric Carboxymaltose, Placebo |
Primary outcome
Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
Time frame: Baseline, Week 4
Post-exercise phosphocreatine recovery time (in seconds) will be used to assess mitochondrial oxidative capacity. It is measured non-invasively with 31P-magnetic resonance spectroscopy.
5 secondary outcomes
Change From Baseline in 6-Minute Walk Test Distance
Time frame: Baseline, Week 4
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score
Time frame: Baseline, Week 4
Change From Baseline in Hemoglobin Levels
Time frame: Baseline, Week 4
Change From Baseline in Serum Ferritin Levels
Time frame: Baseline, Week 4
Change From Baseline in Transferrin Saturation
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Iron-deficiency
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
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
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.
Stuart Katz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferric Carboxymaltose and 31P MRS/MRI in people with Iron-deficiency, run by NYU Langone Health 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 21 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 5 Jul 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Jul 2023). 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?
Change From Baseline in Post-Exercise Phosphocreatine Recovery Time (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2023.