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A Randomized, Double-blind, Multi-center Clinical Trial Prospectively Evaluating Iron Protein Succinylate Oral Solution in Treating Patients With Chronic Heart Failure and Iron Deficiency
This study aims to evaluate the effect of standard heart failure therapy plus oral solution with protein succinylate iron compared to placebo on the primary end point of 6 minute walk distance at 24th week in patients with chronic ejection fraction reduction heart failure and iron deficiency.
Details
| Lead sponsor | Lee's Pharmaceutical Limited |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 600 |
| Start date | 2018-01 |
| Completion | 2019-12 |
Conditions
- Chronic Heart Failure
- Iron-deficiency
Interventions
- Iron protein succinylate oral solution
- standard treatment
Primary outcomes
- The change of 6 Minute walk distances — 24 week
The change of 6 Minute walk distances compared to baseline after patients receiving 24 week treatment.