Chronic Heart FailurePhase 1NCT02737995
Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
A Phase 1 study testing Ferric carboxymaltose infusion in people with Chronic Heart Failure, run by NYU Langone Health.
Trial summary
Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients, but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Ferric carboxymaltose infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent
- Age 21-80 years
- Chronic heart failure >3 months with NYHA Class I-III symptoms
Who cannot join
- Presence of implantable defibrillator, permanent pacemaker not designed for safe use in 3T MRI stud
- Metallic implant or implants that are deemed not suitable for MRI scan on 3T
- Aneurysm clips, cochlear implants, presence of shrapnel in strategic locations, and metal in the eye
- Known claustrophobia or any other history of intolerance of MRI procedure
- Treated diabetes mellitus or hemoglobin A1c (HbA1c) >6.5%
- Any hospitalization <60 days
Show all 20Show fewer
- Myocardial infarction or stroke < 6 months
- Estimated glomerular filtration rate <30 ml/min
- Weight <50 or >120 kg
- Systolic blood pressure <90 mmHg or > 160 mmHg
- Heart rate <50 or >100 beats per minute
- Resting oxygen saturation on room air <92%
- Hemoglobin <11 g/dl
- Serum phosphate below normal range (<2.4 mg/dl)
- Liver function tests (AST, ALT, Alk Phos, or Total Bilirubin) >twice upper limit of normal range
- Pregnancy or current breastfeeding
- Exercise limitation primarily due to valvular heart disease, lung disease, neuromuscular disease, or joint disease
- History of asthma
- History of anaphylaxis
- Known history of intolerance to any formulation of intravenous iron
About this study
Official title: A Pilot Feasibility Study on Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients, but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown. This is a pilot study to determine the feasibility of the use of specialized 31P-MRS and MRI techniques for measurement of skeletal muscle bioenergetics in patients with heart failure with and without functional iron deficiency.
Read the detailed description
This study will obtain pilot feasibility data to explore the relationship between blood biomarkers of functional iron deficiency and skeletal muscle mitochondrial oxidative capacity with 31P-magnetic resonance spectroscopy (MRS) and imaging in heart failure patients.
Twenty (20) subjects will be recruited from the clinical practice of the NYU Advanced Cardiac Therapeutics group at NYU Langone Medical Center.
Twenty (20) subjects will be recruited from the practice of the NYU Advanced Cardiac Therapeutics group at NYU Langone Medical Center. The study will require a maximum of four (4) visits over a period of five (5) weeks. Eligibility for Visits 2-4 will be determined by the screening criteria in Visit 1. It is anticipated that 50% of the screened subjects at Visit 1 will be eligible to participate in Visit 2. Eligibility for participation in Visits 3 and 4 will be determined by the results of the iron biomarkers obtained at Visit 2. We anticipate that 50% of the subjects at Visit 2 will be eligible to participate in Visits 3 and 4. Only subject with functional iron deficiency will participate in Visits 3 and 4. There is no clinical care component for this study.
- Conditions
- Chronic Heart Failure
- Being tested
- Ferric carboxymaltose infusion
- Keywords
- Iron deficiency
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltose infusionDrug
Subjects with functional iron deficiency determined by the results of iron biomarker results at Visit 2 will receive a single dose of intravenous ferric carboxymaltose . The dose of Injectafer will be calculated from a modified Ganzoni equation adapted from previous heart failure clinical trials The maximum dose of Injectafer will be 750 mg. The calculated dose of Injectafer will be diluted in normal saline solution (4 mg/ml) and administered via a volumetric pump administered over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Iron Replacement | Experimental | Not described Receives: Drug: Ferric carboxymaltose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of iron stores
Plantar flexion exercise as determined with a novel dynamic phosphorus magnetic resonance spectroscopy and imaging technique (31P-MRS \& MRI) in heart failure patients (n=10) with and without functional iron deficiency. A spectrally selective three-dimensional turbo spin echo (3D-TSE) echo (3D-TSE) protocol for measurement of phosphocreatine recovery kinetics on a 3T Siemens MRI scanner as previously described (Siemens Medical Solutions, Erlangen, Germany).
Measured: 60 minutes
Skeletal muscle bioenergetics using 31P- MRS Spectroscopy
Plantar flexion exercise with 31P-MRS and MRI in heart failure patients (n=5) with functional iron deficiency. A spectrally selective three-dimensional turbo spin echo (3D-TSE) protocol for measurement of phosphocreatine recovery kinetics on a 3T Siemens MRI scanner (Siemens Medical Solutions, Erlangen, Germany).
protocol for measurement of phosphocreatine recovery kinetics on a 3T Siemens MRI scanner as previously described (Siemens Medical Solutions, Erlangen, Germany).
Measured: 120 Minutes
Secondary outcomes (1)
Functional Capacity
Subjects will be asked to walk along a 30 meter marked path in a corridor at a self-selected pace. Subjects will receive standardized instruction before and during the walking test. The distance walked after 6 minutes (meters) will be recorded.
Measured: Six Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02737995
- Sponsor's protocol ID
- 15-00396
- Status last verified
- Aug 2016
- First submitted
- 8 Apr 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study on Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02737995
- Acronym / sponsor ID
- 15-00396
- Conditions
- Chronic Heart Failure
- Keywords
- Iron deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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.
Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients, but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown. This is a pilot study to determine the feasibility of the use of specialized 31P-MRS and MRI techniques for measurement of skeletal muscle bioenergetics in patients with heart failure with and without functional iron deficiency.
Detailed description
This study will obtain pilot feasibility data to explore the relationship between blood biomarkers of functional iron deficiency and skeletal muscle mitochondrial oxidative capacity with 31P-magnetic resonance spectroscopy (MRS) and imaging in heart failure patients.
Twenty (20) subjects will be recruited from the clinical practice of the NYU Advanced Cardiac Therapeutics group at NYU Langone Medical Center.
Twenty (20) subjects will be recruited from the practice of the NYU Advanced Cardiac Therapeutics group at NYU Langone Medical Center. The study will require a maximum of four (4) visits over a period of five (5) weeks. Eligibility for Visits 2-4 will be determined by the screening criteria in Visit 1. It is anticipated that 50% of the screened subjects at Visit 1 will be eligible to participate in Visit 2. Eligibility for participation in Visits 3 and 4 will be determined by the results of the iron biomarkers obtained at Visit 2. We anticipate that 50% of the subjects at Visit 2 will be eligible to participate in Visits 3 and 4. Only subject with functional iron deficiency will participate in Visits 3 and 4. There is no clinical care component for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron Replacement | Experimental | Drug: Ferric carboxymaltose infusion |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to provide written informed consent
- Age 21-80 years
- Chronic heart failure >3 months with NYHA Class I-III symptoms
Key exclusion criteria (20 listed)
- Presence of implantable defibrillator, permanent pacemaker not designed for safe use in 3T MRI stud
- Metallic implant or implants that are deemed not suitable for MRI scan on 3T
- Aneurysm clips, cochlear implants, presence of shrapnel in strategic locations, and metal in the eye
- Known claustrophobia or any other history of intolerance of MRI procedure
- Treated diabetes mellitus or hemoglobin A1c (HbA1c) >6.5%
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 infusionSubjects with functional iron deficiency determined by the results of iron biomarker results at Visit 2 will receive a single dose of intravenous ferric carboxymaltose . The dose of Injectafer will be calculated from a modified Ganzoni equation adapted from previous heart failure clinical trials The maximum dose of Injectafer will be 750 mg. The calculated dose of Injectafer will be diluted in normal saline solution (4 mg/ml) and administered via a volumetric pump administered over 30 minutes. | Drug | Iron Replacement |
Primary outcome
Biomarkers of iron stores
Time frame: 60 minutes
Plantar flexion exercise as determined with a novel dynamic phosphorus magnetic resonance spectroscopy and imaging technique (31P-MRS \& MRI) in heart failure patients (n=10) with and without functional iron deficiency. A spectrally selective three-dimensional turbo spin echo (3D-TSE) echo (3D-TSE) protocol for measurement of phosphocreatine recovery kinetics on a 3T Siemens MRI scanner as previously described (Siemens Medical Solutions, Erlangen, Germany).
Skeletal muscle bioenergetics using 31P- MRS Spectroscopy
Time frame: 120 Minutes
Plantar flexion exercise with 31P-MRS and MRI in heart failure patients (n=5) with functional iron deficiency. A spectrally selective three-dimensional turbo spin echo (3D-TSE) protocol for measurement of phosphocreatine recovery kinetics on a 3T Siemens MRI scanner (Siemens Medical Solutions, Erlangen, Germany). protocol for measurement of phosphocreatine recovery kinetics on a 3T Siemens MRI scanner as previously described (Siemens Medical Solutions, Erlangen, Germany).
1 secondary outcome
Functional Capacity
Time frame: Six Minutes
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 15 Aug 2016.
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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.
Stuart Katz, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferric carboxymaltose infusion in people with Chronic Heart Failure, run by NYU Langone Health.
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 3 inclusion and 20 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Biomarkers of iron stores (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2016.