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Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT02737995
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Ferric carboxymaltose infusion Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study on Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure
Study Start Date : May 2015
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Experimental: Iron Replacement Drug: Ferric carboxymaltose infusion
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 Measures :
  1. 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).

  2. 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).



Secondary Outcome Measures :
  1. Functional Capacity [ Time Frame: Six Minutes ]
    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.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737995


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Stuart Katz, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02737995     History of Changes
Other Study ID Numbers: 15-00396
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Keywords provided by NYU Langone Health:
Iron deficiency
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs