Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure

Description

The purpose of this study is to determine if oral iron (FE) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure Exercise Testing) and Fe deficiency at 16 weeks. Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral placebo, therapy with oral Fe polysaccharide will be associated with improvement in functional capacity at 16 weeks as assessed by CPET.

Study Start Date

August 2014

Estimated Completion Date

May 2016

Interventions

  • Drug: Polysaccharide Iron Complex 150 mg
  • Drug: Placebo (for Polysaccharide Iron Complex)

Specialties

  • Cardiology: Heart Failure
  • Internal Medicine: Cardiology
  • Physician Assistant: Cardiology

MeSH Terms

  • Heart Failure
  • Polysaccharide

Study ID

Duke University -- Pro00054061

Status

Unknown

Trial ID

NCT02188784

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

220

Sponsor

Duke University

Inclusion Criteria

    1. Age >18 years 2. Previous clinical diagnosis of heart failure with current NYHA Class II-IV symptoms LVEF?0.40 within 1 year prior to consent, and ?3 months after a major change in cardiac status (i.e. CABG or CRT). 3. Serum ferritin between 15-100 ng/ml or serum ferritin between 100-299 ng/ml with transferrin saturation <20% 4. Hemoglobin 9.0-13.5 g/dL at time of enrollment 5. Stable evidence-based medical therapy for HF (including beta-blocker and ACE-inhibitor/ARB unless previously deemed intolerant) for 30 days prior to randomization a. Changes in diuretic dose guided by a patient-directed flexible dosing program are considered stable medical therapy 6. Willingness to provide informed consent

Exclusion Criteria

    1. Presence of a neuromuscular, orthopedic or other non-cardiac condition that prevents the patient from exercise testing on a bicycle/treadmill ergometer and/or inability to achieve an RER ? 1.0 on screening/baseline CPET 2. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) 3. Severe liver disease (ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x normal) 4. Gastrointestinal conditions known to impair Fe absorption (i.e. inflammatory bowel disease) 5. Known active infection as defined by current use of oral or intravenous antimicrobial agents 6. Documented active gastrointestinal bleeding 7. Active malignancy other than non-melanoma skin cancers 8. Anemia with known cause other than Fe deficiency or chronic disease 9. Fe overload disorders (i.e. hemochromatosis or hemosiderosis) 10. History of erythropoietin, IV or oral Fe therapy, or blood transfusion in previous 3 months. 11. Current ventricular assist device 12. Anticipated cardiac transplantation within the next 4 months 13. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade 14. Previous adverse reaction to study drug or other oral Fe preparation 15. Known or anticipated pregnancy in the next 4 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (16)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Michael Givertz MD None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Marc Semigran MD None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles Gordon Huggins MD None None
The University of Vermont Fletcher Allen Health Care - Burlington, Vermont 181.7 miles Peter Van Buren MD None None
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Kenneth Margulies MD None None
Lancaster General Hospital - Lancaster, Pennsylvania 317.2 miles Tareck Nossuli MD None None
Johns Hopkins Hospital - Baltimore, Maryland 356.0 miles Ryan Tedford MD None None
University HospitalsCase Medical Center - Cleveland, Ohio 544.0 miles Guilherme Oliveria MD None None
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Wilson Tang MD None None
Metor Health System - Cleveland, Ohio 549.6 miles Mark Dunlap MD None None
Duke University Medical Center - Durham, North Carolina 608.4 miles G Michael Felker MD None None
Emory University School of Medicine - Atlanta, Georgia 932.0 miles Andrew Smith MD None None
Saint Louis University Hospital - St. Louis, Missouri 1,039.5 miles Paul Hauptman MD None None
Washington University School of Medicine - St. Louis, Missouri 1,039.5 miles Shane LaRue MD None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Margaret Redfield MD None None
University of Utah Hospitals and Clinics - Murray, Utah 2,098.3 miles Stavros Drakos MD None None

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