Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
- Conditions
- Iron-deficiency
- Interventions
- Registration Number
- NCT03218384
- Lead Sponsor
- 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 (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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. Ferric Carboxymaltose 31P MRS/MRI 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 Placebo 31P MRS/MRI 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. Ferric Carboxymaltose Ferric Carboxymaltose 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
- Primary Outcome Measures
Name Time Method Change From Baseline in Post-Exercise Phosphocreatine Recovery Time Baseline, Week 4 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
Name Time Method Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score Baseline, Week 4 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 Baseline, Week 4 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 6-Minute Walk Test Distance Baseline, Week 4 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 Serum Ferritin Levels Baseline, Week 4 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 Baseline, Week 4 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.
Trial Locations
- Locations (1)
New York University School of Medicine
🇺🇸New York, New York, United States