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Trial record 9 of 385 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT03218384
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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
Iron-deficiency 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 7, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

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 Name: 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 Name: Saline




Primary Outcome Measures :
  1. Effects of ferric carboxymaltose 750 mg vs. placebo on change in skeletal muscle mitochondrial oxidative capacity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 Weeks ]
    self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218384


Contacts
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Contact: Stanley Cobos 646 501 2897 stanley.cobos@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Stanley Cobos    646-501-2897    stanley.cobos@nyumc.com   
Principal Investigator: Stuart Katz, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Stuart Katz, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03218384     History of Changes
Other Study ID Numbers: 17-00444
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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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:
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Ferric Compounds
Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Hematinics