Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency

NCT03218384 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: 17-00444
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF). Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low body levels of iron might increase shortness of breath and fatigue.

Conditions

Iron-deficiency

Keywords

Injectafer; ferric carboxymaltose; Supplemental Iron

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Post-Exercise Phosphocreatine Recovery Time

  Post-exercise phosphocreatine recovery time (in seconds) will be used to assess mitochondrial oxidative capacity. It is measured non-invasively with 31P-magnetic resonance spectroscopy.

  Baseline, Week 4

Secondary Outcomes (5)

• Change From Baseline in 6-Minute Walk Test Distance

  Baseline, Week 4

• Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score

  Baseline, Week 4

• Change From Baseline in Hemoglobin Levels

  Baseline, Week 4

• Change From Baseline in Serum Ferritin Levels

  Baseline, Week 4

• Change From Baseline in Transferrin Saturation

  Baseline, Week 4

Study Arms (2)

Ferric Carboxymaltose

EXPERIMENTAL

HF patients with functional iron deficiency assigned to receive one-time dose of Ferric Carboxymaltose 750 mg. Participants will undergo serial assessment before and 4 weeks after study drug administration

Drug: Ferric Carboxymaltose; Device: 31P MRS/MRI

Placebo

ACTIVE COMPARATOR

HF patients with functional iron deficiency assigned to receive one-time dose of Placebo (saline injection). Participants will undergo serial assessment before and 4 weeks after study drug administration.

Drug: Placebo; Device: 31P MRS/MRI

Interventions

Ferric Carboxymaltose DRUG

Intravenous Ferric Carboxymaltose 750 mg mixed under sterile conditions in 100 ml of normal saline for final concentration of 7.5 mg/ml and administered via volumetric infusion pump over 15 minutes.

Also known as: Injectafer

Ferric Carboxymaltose

Placebo DRUG

100 ml of normal saline solution, and administered via volumetric infusion pump over 15 minutes.

Also known as: Saline

Placebo

31P MRS/MRI DEVICE

Each participant will perform the same rhythmic plantar extension exercise protocol twice, for sequential acquisition of magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) measurements. For the exercise protocol, the participant will lay supine on the scanning table with the right leg inside the volume coil. The exercise consists of repeated plantar flexion movements using resistance bands at a frequency of one repetition per second for 1-2 minutes. Data are collected continuously for 2 minutes before the exercise (baseline), during exercise, and 5 minutes after the exercise for the MRS and MRI experiments.

Also known as: 3T Siemens MRI

Ferric Carboxymaltose; Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic NYHA Class II-III heart failure \>3 months
• Guideline-recommended heart failure treatment for \> 3 months
• Hemoglobin \>13 g/dl for men and \>12 g/dl for women
• Functional iron deficiency (defined as serum ferritin level \<100 ng/ml or between 100 and 299 ng/ml with transferrin saturation \<20%)
• Left ventricular ejection fraction \<40%, or left ventricular ejection fraction ≥40% with left atrial enlargement (left atrial volume index \>28 ml/m2) and/or left ventricular hypertrophy (left ventricular mass index \>95 g/m2 (women) or \>115 g/m2 (men) determined by echocardiogram within last 24 months.
• Able and willing to provide written informed consent

You may not qualify if:

• Presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
• Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy
• Weight \<50 kg or \>120 kg
• Coronary or cerebral atherothrombotic events in the past 6 months
• Hospitalization of emergency room visit for heart failure within past 3 months
• ICD shock in last 3 months
• Known peripheral artery disease or ankle-brachial index \<0.9 at screening visit
• Exercise primarily limited by angina, lung disease or neuromuscular disease
• Systolic blood pressure \<100 or \>160 mmHg
• Heart rate \<50 or \>110 min-1
• Estimated glomerular filtration rate \<30 ml/min
• Liver function tests \>3 times upper limit of normal
• Serum phosphate below normal limit
• Pregnant or breast-feeding women
• Women of child-bearing potential unwilling to use recommended contraception methods during the study

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Stuart Katz, MD
• Organization: NYU Langone Health

Stuart.Katz@nyulangone.org

2122633946

Study Officials

• Stuart Katz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: September 7, 2017
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: July 5, 2023
• Results First Posted: July 5, 2023

Record last verified: 2023-06

Locations

US (1)