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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03218384
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
63.8
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ferric Carboxymaltose
  • Drug: Placebo
 Phase 2

Detailed Description

The purpose of this prospective, double blind parallel group randomized study is to compare the effects of ferric carboxymaltose vs. placebo on skeletal muscle mitochondrial oxidative capacity, submaximal exercise tolerance, and health-related quality of life in non-anemic Heart Failure (HF) patients with functional iron deficiency.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
Actual Study Start Date :
Sep 7, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ferric carboxymaltose

32 eligible subjects will be randomly assigned (1:1) to ferric carboxymaltose 750 mg or placebo (normal saline)

Drug: Ferric Carboxymaltose
750 MG Iron Per 15 ML Injectable Solution
Other Names:
  • Injectafer

    		•
    Active Comparator: Placebo

    32 eligible subjects will be randomly assigned (1:1) to ferric carboxymaltose 750 mg or placebo (normal saline)

    Drug: Placebo
    normal saline
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effects of ferric carboxymaltose 750 mg vs. placebo on change in skeletal muscle mitochondrial oxidative capacity [4 Weeks]

      Post-exercise phosphocreatine recovery time measured non-invasively with 31P-magnetic resonance spectroscopy).

    Secondary Outcome Measures

    1. Change in 6-minute walk test distance from baseline to 4 weeks [4 Weeks]

      Used in the assessment of patients with a variety of cardiopulmonary diseases including pulmonary arterial hypertension (PAH). ... It simply measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.

    2. Change in Kansas City Cardiomyopathy Questionnaire score from baseline to 4 weeks [4 Weeks]

      self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    • Treatment with oral iron supplements (except multivitamins) in past year

    • Treatment with intravenous iron in past year

    • Treatment with erythropoiesis stimulating agents in the past year

    • Known intolerance of intravenous iron

    • History of anaphylaxis

    • Participation in another clinical trial within last 30 days.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Stuart Katz, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03218384
    Other Study ID Numbers:
    • 17-00444
    First Posted:
    Jul 14, 2017
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by NYU Langone Health
    Injectafer
    ferric carboxymaltose
    Supplemental Iron
    Additional relevant MeSH terms:
    Heart Failure
    Anemia, Iron-Deficiency

    Study Results

    No Results Posted as of Feb 3, 2022