CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
Polysaccharide Iron Complex 150 mg +1 moredrug
Likely dose
Polysaccharide Iron Complex 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02188784
NCT02188784Phase 3Completed
CompareCT.gov

Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure

Adrian Hernandez·interventional·Posted Jul 14, 2014·Updated Jul 11, 2017

In Brief

A Phase 3 clinical trial evaluating Polysaccharide Iron Complex 150 mg and Placebo (for Polysaccharide Iron Complex) for Chronic Heart Failure. Completed, enrolled 225 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 14, 2014
Enrollment StartSep 3, 2014
Primary CompletionApr 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.0 years ago

Interventions

Polysaccharide Iron Complex 150 mgdrug

Oral Iron

Placebo (for Polysaccharide Iron Complex)drug

Sugar capsule designed to mimic Polysaccharide Iron Complex.