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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03344523
Study type Interventional
Source Lee's Pharmaceutical Limited
Contact
Status Not yet recruiting
Phase Phase 4
Start date January 2018
Completion date December 2019

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