Iron-deficiency Clinical Trial
Official title:
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
Verified date | June 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | April 4, 2022 |
Est. primary completion date | April 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Week 4 | |
Secondary | 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. | Baseline, Week 4 | |
Secondary | 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. | Baseline, Week 4 | |
Secondary | 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. | Baseline, Week 4 | |
Secondary | 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. | Baseline, Week 4 | |
Secondary | 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. | Baseline, Week 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04949165 -
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
|
N/A | |
Active, not recruiting |
NCT03516734 -
Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh
|
N/A | |
Completed |
NCT03572010 -
Stable Iron Isotope Method in HIV+ and HIV- Children
|
N/A | |
Active, not recruiting |
NCT03703726 -
Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.
|
N/A | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Not yet recruiting |
NCT05395468 -
Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.
|
||
Withdrawn |
NCT03800446 -
Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
|
N/A | |
Not yet recruiting |
NCT03353662 -
Sub Regional Micronutrient Survey in Ethiopia
|
||
Completed |
NCT03819530 -
Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study
|
N/A | |
Recruiting |
NCT04144790 -
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
|
||
Completed |
NCT03957057 -
Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia
|
Phase 3 | |
Completed |
NCT03642223 -
Central and Peripheral Adiposity and Iron Absorption
|
N/A | |
Not yet recruiting |
NCT05407987 -
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
|
Phase 3 | |
Withdrawn |
NCT03873584 -
Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
|
||
Enrolling by invitation |
NCT03897673 -
Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas
|
N/A | |
Completed |
NCT04359368 -
Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
|
||
Active, not recruiting |
NCT04778072 -
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
|
N/A | |
Enrolling by invitation |
NCT05750940 -
Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
|
||
Recruiting |
NCT05126901 -
Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
|
Phase 3 | |
Recruiting |
NCT05609318 -
Imaging Intravenous Iron
|