Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

NCT02737995 | Completed Phase 1

• 1 other identifier: 15-00396
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Heart Failure

Keywords

Iron deficiency

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  120 Minutes

Secondary Outcomes (1)

• Functional Capacity

  Six Minutes

Study Arms (1)

Iron Replacement

EXPERIMENTAL

Drug: Ferric carboxymaltose infusion

Interventions

Ferric carboxymaltose infusion DRUG

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.

Iron Replacement

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent
• Age 21-80 years
• Chronic heart failure \>3 months with NYHA Class I-III symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stuart Katz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 14, 2016
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-08