NCT03344523

Evaluating Iron Protein Succinylate Oral Solution in Treating Chronic Heart Failure and Iron Deficiency

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This clinical trial was designed as a multicenter, prospective, randomized, double-blind controlled study. Patients were randomly divided into one of two treatment groups: Control group: standard treatment + placebo（1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）. Test group: standard treatment + Iron protein succinylate oral solution (1 bottle orally, twice daily, take orally before meals, duration of treatment 16-24 weeks）. Sample size calculation is according to the change of 6 Minute walk distance from the baseline at 24 weeks, it is estimated the mean difference between two groups is 20 meter, standard deviation 80 meter, statistical power 80%, type I error 0.05, follow up loss 15%，estimated total sample size 600.

Conditions

• Chronic Heart Failure
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Iron protein succinylate oral solution	Iron protein succinylate oral solution
OTHER	standard treatment	standard treatment

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-11-17
• Last updated: 2017-11-17