Phase 3
N=225
Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure
Chronic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02188784 ↗Enrolled (actual)
225
Serious AEs
8.9%
Results posted
May 2017
Primary outcome: Primary: Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption) — 28.04; 3.90 mL/min — p=0.4570
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Polysaccharide Iron Complex 150 mg (Drug); Placebo (for Polysaccharide Iron Complex) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Adrian Hernandez
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption) |
28.04; 3.90 | 0.4570 |
| SECONDARY Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT) |
12.65; 16.63; 10.76; 30.94 | 0.9487 |
| SECONDARY Change in Plasma NT-pro BNP |
119.36; -70.88 | 0.4296 |
| SECONDARY Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score |
3.25; 0.58; 3.42; 4.11 | 0.0722 |
| SECONDARY Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET |
2.63; -0.95 | 0.0643 |
| SECONDARY Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2 |
-0.48; -1.31 | 0.4006 |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02188784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.