Evaluation of the effect of iron replacement therapy on symptom and quality of life in patients with chronic heart failure and iron deficiency who referred to Isfahan's Shariarti hospital in 1392-93
This is a clinical trial for evaluation of iron replacement therapy on symptoms and quality of life in patients with chronic heart failure and iron deficiency anemia . in this study 46 patients with stable chronic heart failure and iron deficiency who are content to take part in this study and have no hemoglobinopathy , follic acid or vitamin B12 deficiency will be registered in the study and will recieve parental iron. before starting intervention hemoglobin level,serum iron,Total iron binding capacity,transferrin saturation and ferritin will be measured.also patient's quality of life and 6 minute walk test will be evaluated.then iron depletion will be calculated by:
3.2(normal Hemoglobin-patient Hemoglobin)*body weight+1000 for males
and 3.2(normal Hemoglobin-patient Hemoglobin)*body weight+500 for females
Having gotten patients consent, they will treated by 200 mg intravenous iron every week and after complete replacement therapy , patients will be reevaluated in terms of hemoglobin level,serum iron,total iron binding capacity,transferrin saturation, ferritin , patient's quality of life and 6 minute walk test.
Finally all data will be analyzed by statistical software
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112813828N5
Registration date:2014-03-18, 1392/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-18, 1392/12/27
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University,Najafabad branch
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of iron replacement therapy on symptom and quality of life in patients with chronic heart failure and iron deficiency who referred to Isfahan's Shariarti hospital in 1392-93
Public title
Effect of iron replacement therapy in patients with chronic heart failure and iron deficiency anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:patient's consent;patients with stable chronic heart failure;Iron deficiency anemia;Age between 30 and 75 years old
exclusion criteria:No consent to participate in study;patient with unstable heart failure;Patient with hemoglobinopathy;Patient with B12 and follic acid deficiency;Pregnancy;Age less than30 or more than75 years old
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
azadi square
City
isfahan
Postal code
Approval date
2014-02-06, 1392/11/17
Ethics committee reference number
492038
Health conditions studied
1
Description of health condition studied
chronic heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
6 Minute Walk Test
Timepoint
Before intervention and also afte iron deficiency anemia treatmen
Method of measurement
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes
2
Description
Quality Of Llife
Timepoint
Before intervention and also after iron deficiency anemia treatment
Method of measurement
Quality Of Llife Questionnaire
3
Description
New York Heart Association Functional Classification
Timepoint
Before intervention and also afte iron deficiency anemia treatmen
Method of measurement
patient's words
Secondary outcomes
1
Description
serum creatinine
Timepoint
before intervention and after iron deficiency anemia treatment
Method of measurement
jaffe
2
Description
Glomerular filtration rate
Timepoint
before intervention and after iron deficiency anemia treatment
Method of measurement
(140-age)*mass(in kilogram)*(0.85 if female/72*serum creatinine(in mg/dl)
Intervention groups
1
Description
Before starting intervention hemoglobin level,serum iron,Toral iron binding capacity,transferrin saturation and ferritin will be measured.also patient's quality of life and 6 minute walk test will be measured.then iron depletion will be calculated
then patients will be received 200 mg intravenous iron every week and after iron replacement therapy, patients will be reevaluated in terms of hemoglobin level,serum iron,total iron binding capacity,transferrin saturation. ferritin , patient's quality of life and 6 minute walk test.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Doctor Shariat iHospital
Full name of responsible person
Dr Mirdamadi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr.Mirdamadi
Street address
Najafabad, Isfahan
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Najafabad Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr.Mirdamadi
Position
Cardiologist,Fellowship of Echocardiography/Assistant professor of medical school
Other areas of specialty/work
Street address
Sheikhbahaei Street, Isfahan Hospital,
City
Isfahan
Postal code
Phone
+98 31 1233 0015
Fax
+98 31 1223 8028
Email
drsamirdamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr.Mirdamadi
Position
Cardiologist,Fellowship of Echocardiography/Assistant professor of medical school
Other areas of specialty/work
Street address
Sheikhbahaei Street, Isfahan Hospital,
City
Isfahan
Postal code
Phone
+98 31 1233 0015
Fax
+98 22 38028
Email
drsamirdamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)