Back to resultsIron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ferric carboxymaltose infusion
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring Iron deficiency
Eligibility Criteria
Inclusion Criteria:
- Able and willing to provide written informed consent
- Age 21-80 years
- Chronic heart failure >3 months with NYHA Class I-III symptoms
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iron Replacement
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02737995
Brief Title
Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
Official Title
A Pilot Feasibility Study on Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Iron deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron Replacement
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biomarkers of iron stores
Description
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).
Time Frame
60 minutes
Title
Skeletal muscle bioenergetics using 31P- MRS Spectroscopy
Description
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).
Time Frame
120 Minutes
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
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.
Time Frame
Six Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able and willing to provide written informed consent
Age 21-80 years
Chronic heart failure >3 months with NYHA Class I-III symptoms
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Katz, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
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