search
Back to results

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

Primary Purpose

Iron-deficiency

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose
Placebo
31P MRS/MRI
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-deficiency focused on measuring Injectafer, ferric carboxymaltose, Supplemental Iron

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric Carboxymaltose

Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in 6-Minute Walk Test Distance
The 6-minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score
23-item self-assessment of symptoms, physical and social limitations, and quality of life in patients with heart failure. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best. The total score ranges from 0-100, with higher scores indicating better health status. An increase in scores indicates health status improved during the observational period.
Change From Baseline in Hemoglobin Levels
Hemoglobin is a protein in red blood cells that carries oxygen. Hemoglobin levels (g/dL) were measured in laboratory analyses using patient blood samples.
Change From Baseline in Serum Ferritin Levels
Ferritin is a blood protein that contains iron. Serum ferritin levels (ng/ml) were measured in laboratory analyses using patient blood samples.
Change From Baseline in Transferrin Saturation
Transferrin saturation, measured as a percentage, is the value of serum iron divided by the total iron-binding capacity of the available transferrin. Transferrin saturation was measured in laboratory analyses using patient blood samples.

Full Information

First Posted
July 12, 2017
Last Updated
June 13, 2023
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT03218384
Brief Title
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
Official Title
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to complete enrollment as planned.
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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 (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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
Keywords
Injectafer, ferric carboxymaltose, Supplemental Iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric Carboxymaltose
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose
Other Intervention Name(s)
Injectafer
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
100 ml of normal saline solution, and administered via volumetric infusion pump over 15 minutes.
Intervention Type
Device
Intervention Name(s)
31P MRS/MRI
Other Intervention Name(s)
3T Siemens MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
Description
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.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in 6-Minute Walk Test Distance
Description
The 6-minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score
Description
23-item self-assessment of symptoms, physical and social limitations, and quality of life in patients with heart failure. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best. The total score ranges from 0-100, with higher scores indicating better health status. An increase in scores indicates health status improved during the observational period.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Hemoglobin Levels
Description
Hemoglobin is a protein in red blood cells that carries oxygen. Hemoglobin levels (g/dL) were measured in laboratory analyses using patient blood samples.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Serum Ferritin Levels
Description
Ferritin is a blood protein that contains iron. Serum ferritin levels (ng/ml) were measured in laboratory analyses using patient blood samples.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Transferrin Saturation
Description
Transferrin saturation, measured as a percentage, is the value of serum iron divided by the total iron-binding capacity of the available transferrin. Transferrin saturation was measured in laboratory analyses using patient blood samples.
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Katz, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs