Trial Outcomes & Findings for An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function (NCT NCT05309499)

Last Updated: 2026-01-05

Results Overview

Using a standard transthoracic echocardiography sequence, each myocardial segment is assigned a score from 1 to 3. we used the 16 segment model of myocardial segmentation Each segment is then scored, using the following criteria: normokinesia (1 point) normal wall thickening and endocardial excursion hypokinesia (2 points) reduced wall thickening, reduced endocardial excursion akinesia (3 points) The wall motion score index is then calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). A WMSI of 1.0 (16/16) is considered normokinetic, and correlates with a CMRI calculated ejection fraction of 64%, whereas a WMSI of 3.0 correlates with an ejection fraction of 12% and is considered akinetic. There are no spetial units of measure for it.

Recruitment status

COMPLETED

Study phase

Target enrollment

298 participants

Primary outcome timeframe

1 year

Results posted on

2026-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	FCM Group The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. ferric carboxymaltose: ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group	Ferrous Sulphate Group 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group	Group With Normal Iron Status Patiants with normal iron status
Overall Study STARTED	99	100	99
Overall Study COMPLETED	99	100	99
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FCM Group n=99 Participants The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. ferric carboxymaltose: ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group	Ferrous Sulphate Group n=100 Participants 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group	Group With Normal Iron Status n=99 Participants Patiants with normal iron status	Total n=298 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 10.2 • n=9667 Participants	64.3 years STANDARD_DEVIATION 8.8 • n=6597 Participants	66.1 years STANDARD_DEVIATION 10 • n=16264 Participants	65.7 years STANDARD_DEVIATION 8.5 • n=31 Participants
Sex: Female, Male Female	49 Participants n=9667 Participants	40 Participants n=6597 Participants	24 Participants n=16264 Participants	113 Participants n=31 Participants
Sex: Female, Male Male	50 Participants n=9667 Participants	60 Participants n=6597 Participants	75 Participants n=16264 Participants	185 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	99 Participants n=9667 Participants	100 Participants n=6597 Participants	99 Participants n=16264 Participants	298 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	FCM group n=99 Participants The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. ferric carboxymaltose: ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group	Ferrous sulphate group n=100 Participants 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group	Group with normal iron status n=99 Participants Patiants with normal iron status
Decrease in the Wall Motion Score Index	53 Participants	58 Participants	46 Participants

SECONDARY outcome

Timeframe: 1 year

composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations.

Outcome measures

Outcome data not reported

Adverse Events

FCM Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ferrous Sulphate Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group With Normal Iron Status

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Niiaz Khasanov

Kazan State medical Universety

Phone: +79050204407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place