Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Heart Failure

In brief

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 (oxygen uptake) by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) 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.

Key facts

Study ID

NCT02188784

Run by

Adrian Hernandez

People needed

225

Starts

2014-09-03

Expected to finish

2016-04-06

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Previous clinical diagnosis of heart failure with current New York Heart Association (NYHA) Class II-IV symptoms LVEF≤0.40 within 2 years prior to consent, and ≥3 months after a major change in cardiac status (i.e. CABG or CRT).
• Serum ferritin between 15-100 ng/ml or serum ferritin between 100-299 ng/ml with transferrin saturation <20%
• Hemoglobin 9.0-13.5 g/dL (males), 9-13.5 (females) at time of enrollment
• Stable evidence-based medical therapy for HF (including beta-blocker and ACE-inhibitor/ARB unless previously deemed intolerant, and diuretics as necessary) with </= 100% change in dose for 30 days prior to randomization
• a. Changes in diuretic dose guided by a patient-directed flexible dosing program are considered stable medical therapy
• Willingness to provide informed consent

You may not qualify if…

• 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
• Severe renal dysfunction (eGFR< 20 ml/min/1.73m2)
• Severe liver disease (ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x normal)
• Gastrointestinal conditions known to impair Fe absorption (i.e. inflammatory bowel disease)
• Known active infection as defined by current use of oral or intravenous antimicrobial agents
• Documented active gastrointestinal bleeding
• Active malignancy other than non-melanoma skin cancers
• Anemia with known cause other than Fe deficiency or chronic disease
• Fe overload disorders (i.e. hemochromatosis or hemosiderosis)
• History of erythropoietin, IV or oral Fe therapy, or blood transfusion in previous 3 months.
• Current ventricular assist device
• Anticipated cardiac transplantation within the next 4 months
• Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
• Previous adverse reaction to study drug or other oral Fe preparation
• Known or anticipated pregnancy in the next 4 months

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals-Case Medical Center — Cleveland, Ohio, United States
• Metor Health System — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Utah Hospitals and Clinics — Murray, Utah, United States
• The University of Vermont - Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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