Status:
COMPLETED
Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure
Lead Sponsor:
Adrian Hernandez
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (Cardi...
Detailed Description
Therapeutic options to further improve functional capacity and symptoms in HF beyond neurohormonal antagonism are limited. Studies have demonstrated impaired oxidative capacity of skeletal muscle amon...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2016
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT02188784
Start Date
September 3 2014
End Date
April 6 2016
Last Update
July 11 2017
Active Locations (17)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Tufts Medical Center
Boston, Massachusetts, United States, 02111
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114