Protocol summary

Summary
Although dozen of cardiovascular risk factors have been recently identified, taurine deficiency has been recently introduced as a cardiovascular risk factor. This factor has been poorly investigated in patients afflicted with Cardiac Heart Failure (CHF). Sixteen patients ages between 50 to 65 yrs old, categorized in classes II & III, who were randomly divided into the intervention (taurine) and placebo groups in order to study the effect of taurine supplementation on the cardiovascular physiological markers in patients with CHF. The taurine group received 1.5 gr; 3 times daily of 500 mg capsules and the placebo group received starch capsules for a period of 2 weeks. Systolic and diastolic blood pressure, heart rate, maximal activity time, Vo2 peak and plasma tourine, cardiac tropponin I and CPK-MB concentrations were measured and compared before and after taurine supplementation. Data was analyzed by using dependent and independent t- student tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903094058N1
Registration date: 2008-03-20, 1387/01/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2008-03-20, 1387/01/01
Registrant information
Name
Mahshid Kadkhodaei Khalafi
Name of organization / entity
Medical University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 6688 7472
Email address
pcu@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
one third by Loghman Hospital, Shahid Beheshti University of Medical Sciences and the rest by investigator
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2008-06-18, 1387/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Physiological and Functional Changes after the short term Taurine Supplementation in patient with Cardiac Heart Failure Complication
Public title
Effect of Taurine on Physiologic and functional changes in patients with Cardiac heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
1- Heart failure functional clas of II and III 2- Ejection fraction in less than 50% of left ventricular 3- All patients were candidate for some protocol treatment (PCI - PTCA - open heart surgery) 3- Subjects should not have received a variety of vitamins and minerals 4-should not be sensitive to Sulfur 5-should not have disability
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
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
Shahid Beheshti Medical University
Street address
Next to The Talaghani Hospital - Parvaneh Street -Tabnak street - Shahid Chamran Highway
City
Tehran
Postal code
1983963113
Approval date
2008-11-28, 1387/09/08
Ethics committee reference number
525-5657-117-01-2008

Health conditions studied

1

Description of health condition studied
Cardiovascular changes due to Taurine supplementation
ICD-10 code
-
ICD-10 code description
-

2

Description of health condition studied
Heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure

Primary outcomes

1

Description
Plasma Taurine
Timepoint
2 Weeks after & before supplementation
Method of measurement
HPLC (High Chromatography Reverse)

Secondary outcomes

1

Description
Troponin I
Timepoint
2 Weeks after & before supplementation
Method of measurement
Elisa Method

2

Description
Blood pressure & Heart rate
Timepoint
2 Weeks after & before supplementation
Method of measurement
Stethoscope - Treadmill - Instrument of control Blood presure

3

Description
CPK-MB
Timepoint
2 Weeks after & before supplementation
Method of measurement
Immunological

4

Description
vo2 max
Timepoint
2 Weeks after & before supplementation
Method of measurement
peak o2 (15): 3(time)021/0-2(time)451/0+(time)379/1- 8/14 =Peak oxygen consumption

5

Description
Peak of Activity
Timepoint
2 Weeks after & before supplementation
Method of measurement
Treadmill

Intervention groups

1

Description
Three Times Per day - copsule of Taurine 500 mg -during 14 days
Category
Prevention

2

Description
Capsule of starch -500 mg- Three times Per day - during 14 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hospital-Tehran
Full name of responsible person
Mahshid Kadkhodaei Khalafi
Street address
Loghman Hospital, Kamali st.,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti Medical Universiy
Full name of responsible person
Mr Dr Beyranvand
Street address
Medical unit - Parvaneh st- Kodak yar st- Chamran highway
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical Universiy
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
University of medical Shahid Beheshti
Full name of responsible person
Mahshid Kadkhodaei Khalafi
Position
Bachelor of Nursing -Master of Science (physical Education)
Other areas of specialty/work
Street address
CCU unit in Loghman Hospital, Kamali s
City
Tehran
Postal code
Phone
+98 21 6688 7472
Fax
Email
mahshid_kadkhodaei@yahoo.com; vdabidiroshan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of physical education and sport sciences
Full name of responsible person
Dabidi Roshan Valiollah( Ph.D)
Position
PhD of physical education and sport sciences
Other areas of specialty/work
Street address
College of physical education and sport sciences -university of Mazandaran - Babolsar-
City
Babolsar
Postal code
Phone
+98 11 2526 3818
Fax
Email
vdabidiroshan@yahoo.com; mahshid_kadkhodaei@yahoo.com; beyran4@yahoo.com; choobineh@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Loghman Hospital
Full name of responsible person
Mahshid Kadkhodaei Khalafi
Position
Other areas of specialty/work
Street address
City
Postal code
13459
Phone
+98 21 6688 7472
Fax
Email
mahshid_kadkhodaei@yahoo.com; vdabidiroshan@yahoo.com; beyran4@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...