Comparison of the effect of oral and intravenous iron supplementation on quality of life and function of patients with heart failure: a randomized clinical trial

Determination and comparison of the effect of oral and intravenous iron supplementation on quality of life and function of patients with heart failure: a randomized clinical trial

Clinical trial with control group, with parallel groups, randomized, phase 3 on 180 patients to allocate consumption to the subjects will use the randomized block method. The website http://www.randomization.com will also be used for randomization.

One handerd eighty patients with heart failure referred to the outpatient clinic of Dr. Heshmat Rasht Hospital. patients in two groups of 90 will be subjected to intervention with oral iron supplement (furosulfate) 150 mg twice a day for 16 weeks and the other group with injectable iron supplement. And the placebo control group in the group receiving Becomplex oral iron supplement and placebo in the group receiving injectable iron supplement is oral multivitamin.

Inclusion criteria: patients with heart failure, age over 18 years and with serum levels of ferritin<100 or TS<20% and ferritin 100-300 and hemoglobin below 15 Exclusion criteria: , acute heart failure

Intervention group: one group receiving oral iron supplement 150 mg twice a day for 16 weeks and another group receiving injectable iron supplement Control group: placebo in the oral iron group, Becomplex injection and placebo in the iron injection group, taking oral multivitamins

Quality of life and performance of patients

The method of sampling and randomization of the parallel-group clinical trial study will be stratified block randomization. each person was randomly assigned to the intervention or control group using 1: 4 random blocks. Took. In this method, each group will be assigned one of the letters A or B. The website will also be used for randomization. The list of codes obtained from this website will be provided to the researchers, and each referring patient who met the inclusion criteria and did not meet the inclusion criteria and was willing to participate in the study, first entered the desired age group and based on The assigned code A or B enters the design. For concealment, in this study, random allocation concealment, which is the method used to execute a random sequence on the study participants, will be used in such a way that the assigned group is not known before the individual is assigned. In this way, using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.