Clinical trial NCT03218384: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Iron-deficiency
Keywords: Injectafer
ferric carboxymaltose
Supplemental Iron
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in 6-Minute Walk Test Distance
timeFrame: Baseline, Week 4
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score
timeFrame: Baseline, Week 4
measure: Change From Baseline in Hemoglobin Levels
timeFrame: Baseline, Week 4
measure: Change From Baseline in Serum Ferritin Levels
timeFrame: Baseline, Week 4
measure: Change From Baseline in Transferrin Saturation
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: