Heart Failure Clinical Trial

Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure

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 (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.

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Full 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 among HF patients, which may contribute to symptoms of breathlessness and persistent fatigue.

In addition to its role in erythropoiesis, iron (Fe) plays a critical role in skeletal muscle's oxygen (O2)-storage capacity (myoglobin) and systemic aerobic energy production. As Fe deficiency is common in patients with symptomatic HF, repletion of iron stores may improve submaximal exercise capacity among these patients beyond the effects on erythropoiesis.

While intravenous Fe repletion in HF patients with mild Fe-deficiency (i.e. Ferritin <100 or Ferritin 100-299 with transferrin saturation <20%) with or without anemia global well-being and functional status, oral Fe repletion has not been studied. Furthermore, the efficacy of oral Fe to replete iron stores in a similar population and its impact on functional capacity, measured objectively by peak VO2, remains unknown.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
a. Changes in diuretic dose guided by a patient-directed flexible dosing program are considered stable medical therapy

Willingness to provide informed consent

Exclusion Criteria:

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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

225

Study ID:

NCT02188784

Recruitment Status:

Completed

Sponsor:

Adrian Hernandez

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There are 16 Locations for this study

See Locations Near You

Emory University School of Medicine
Atlanta Georgia, 30322, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Saint Louis University Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
University Hospitals-Case Medical Center
Cleveland Ohio, 44106, United States
Metor Health System
Cleveland Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17603, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Utah Hospitals and Clinics
Murray Utah, 84107, United States
The University of Vermont - Fletcher Allen Health Care
Burlington Vermont, 05401, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

225

Study ID:

NCT02188784

Recruitment Status:

Completed

Sponsor:


Adrian Hernandez

How clear is this clinincal trial information?

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