Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Ferric Compounds; Iron

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