NCT02737995

Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

A Pilot Feasibility Study on Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-01-01
• First posted: 2016-04-14
• Last updated: 2016-08-15