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Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study

NCT04225728 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-01-13

No results posted yet for this study

Summary

ERADAL-HF is a double blinded, multi-centre, prospective, randomized, three arm study, enrolled ambulatory patients with chronic heart failure \[New York Heart Association (NYHA) class II/III\], with iron deficiency \[defined as ferritin \<100 ng/mL, or ferritin 100-300 ng/mL if transferrin saturation (TSAT) \<20%\] and haemoglobin (Hb) \< 15 g/dL. Patients were randomized 1:1:1 to treatment into three arms: a first group treated with intravenous iron supplementation, a second treated by intramuscular iron supplementation and the third one which have received placebo. These patients were followed-up during a period of 04 weeks.

The aim of this study is to assess the short term effect of parenteral iron supplementation on exercise tolerance and oxidative stress in patients with stable chronic heart failure and iron deficiency

Conditions

Interventions

DRUG

Iron Sucrose IV

Intervention will consisted of the administration for the IV route. -The IV route in two doses will be diluted bolus injection of iron or normal saline at day 0 and day 14.

DRUG

Ferric polymaltose hydroxide complex IM

Intervention will consisted of the administration for the IM route. Drug will be given in two series of injection; the first series will began at day 0 and consist of administration of 300 mg of iron per day in intramuscular injection up to the half of the total dose and the second series will began at day 14 for the administration of the other half with the same scheme than the first.

OTHER

Saline solution

100 ml i.v. of normal saline administered at Day 0 and at day 14.

Sponsors & Collaborators

  • CN NGANOU-GNINDJIO, MD, MSc

    lead OTHER_GOV

Principal Investigators

  • Chris Nadege NGANOU-GNINDJIO, MD, MAS · Yaounde Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Cameroon

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225728 on ClinicalTrials.gov