We hypothesized that Thiamine supplementation could significantly reduce the signs and symptoms of congestive heart failure (CHF) and improve the cardiac function as evaluated by conventional echocardiography.
In this double blinded randomized controlled trial, 44 CHF patients will be divided into 2 equal groups to receive 300 mg/day oral thiamine or placebo. Every subject il undergo a thorough physical examination with respect to cardiovascular symptoms and transthoracic echocardiography. Patients of each group will be check at 1 and 6 months for any changes in the CHF related symptoms and also echocardiographic features will be check at these time points. At the end of the trial, the changes in signs, symptoms, clinical findings and also echocardiographic evaluations will be compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311019768N2
Registration date:2013-11-12, 1392/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-12, 1392/08/21
Registrant information
Name
Akbar Shafiee
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
shafiee@leydenacademy.nl
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-01, 1392/01/12
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use of Thiamine supplementation versus placebo on the cardiac function in chronic heart failure patients
Public title
Use of Thiamine supplementation versus placebo on the cardiac function in chronic heart failure patients referred to the cardiology clinic of Imam Khomeini Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Consent to take part in the study; Treatment with Furosemide; Known case of congestive heart faiure with ejection fraction<40% and at least on of these criteria: 1-Dyspnea or orthopnea, 2- Positive hepatojugular reflux, 3- Interstitial transudation in the chest X-ray. 4- Brain natriuretic peptide (BNP)=>39 ng/L.
Exclusion: 1-Acute heart failure; Vitamine supplementation at the time of first visit; Renal insufficiency (serum creatinine>250 micromol/L; pregnancy.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Imam Khomeini Hospital, Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Dr. Gharib st
City
Tehran
Postal code
Approval date
2013-05-19, 1392/02/29
Ethics committee reference number
309-130-د-92
Health conditions studied
1
Description of health condition studied
Congestive Heart Failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart disease
Primary outcomes
1
Description
Ejection fraction increase
Timepoint
1 month and 3 months after recruitment
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Improvement in the clinical symtoms
Timepoint
1 and 3 months after recruitment
Method of measurement
Interview and physical excmination
Intervention groups
1
Description
300 mg Thiamine daily as a single oral tablet
Category
Treatment - Drugs
2
Description
Similar tablet in shape containing placebo. once daily, oral
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Reza Rahmani
Street address
Keshavarz Blvd, Dr. Gharib St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imam Khomeini hospital, Tehran University of Medical Sciences
Full name of responsible person
Reza Rahmani
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam Khomeini hospital, Tehran University of Medical Sciences
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
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Full name of responsible person
Akbar Shafiee
Position
MD, MSc
Other areas of specialty/work
Street address
North Kargar Ave.
City
Tehran
Postal code
1411313138
Phone
00
Fax
Email
leo71538@yahoo.com
Web page address
Dr_shafiee@alborzi.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khoemini Hospital, Tehran University of medical sciences
Full name of responsible person
Reza Rahmani
Position
Cardiologist
Other areas of specialty/work
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Postal code
Phone
+98 21 6640 4377
Fax
Email
r_rahmani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Nemati
Position
Resident of Cardiology
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
nematighalb@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)