Evaluation of the effects of complementary creatine monohydrate and exercise on inflamatory markers and endotelial functions among patients with cardiac failure in comparison with control group
This study aims to evaluate the effects of complementary creatine monohydrate and regular exercise on inflammatory markers and endothelial function among patients with chronic cardiac failure. This study is performed by an interventional double blind investigation among 100 patients who showed cardiac symptoms and LVEF less than 45% and were categorised among those with functional class equal or less than III according to NYHA classification. After completion of consent form, patients were divided into intervention and control groups randomly. Intervention group receives creatine monohydrate supplement as much as 5 grams dissolved in water daily and regular exercise for 12 weeks and control group receive maltodextrin 5gr/daily for12 weeks. For measuring different markers including P-selectine, ICAM-1, IL-6, hs-CRP and VCAM-1 and comparison the results between interventional and control groups, patients are taken blood samples at the start and end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061718128N1
Registration date:2014-08-29, 1393/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
Farajollah Hemati
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1334 3456
Email address
hemati-f@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Researches and Technical information, Ilam University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-07-11, 1393/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of complementary creatine monohydrate and exercise on inflamatory markers and endotelial functions among patients with cardiac failure in comparison with control group
Public title
The effects of creatine monohydrate and exercise on congestive heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: being outpatient; LVEF≤ 45%; Functional class≥ III NYHA.
Excluding criteria: Uncontrolled arrhythmia; persistent and severe chest pain; glucosamide or mineral vitamin consumption; known renal failure; arterial abnormalities; sensitive to Sulfur Components; not regularly participation in the study performances.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ilam University of Medical Sciences
Street address
ٍEthics committee, Banganjab, Ilam University of Medical Sciences
City
Ilam
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
EC/93/H/233
Health conditions studied
1
Description of health condition studied
Cardiac failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
High sensitive C reactive protein
Timepoint
start and end of intervention
Method of measurement
serum level of marker using Bender Medsystem kits
2
Description
IL6
Timepoint
start and end of intervention
Method of measurement
serum level of marker using Bender Medsystem kits
3
Description
P-selection
Timepoint
start and end of intervention
Method of measurement
serum level of marker using Biosource International Kit
4
Description
ICAM-1
Timepoint
start and end of intervention
Method of measurement
serum level of marker using Biosource International Kit
5
Description
VCAM-1
Timepoint
start and end of intervention
Method of measurement
serum level of marker using Biosource International Kit
Secondary outcomes
empty
Intervention groups
1
Description
Interventional group: Receive creatine monohydrate complemntary and regular exercises until 12 weeks
Category
Rehabilitation
2
Description
Control group receive maltodextrin 5gr/daily without exercise untill 12 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sport and Physical Medicine Clinic
Full name of responsible person
Dr Farajollah Hemati
Street address
Sport and Physical Medicine Clinic, 22 Bahman Square, Ilam city
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Morovat Taherikalani
Street address
Vice Chancellor for researches and Technology, Banganjab, Ilam University of Medical Sciences
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Dr Farajollah Hemati
Position
Asistant prof., specialist in sport medicine
Other areas of specialty/work
Street address
Dept. of Internal Medicine, Faculty of Medicine, Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 84 1223 5738
Fax
Email
hemati-f@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Khairollah Asadollahi
Position
Associate prof. Epidemiologist
Other areas of specialty/work
Street address
Dept. Epidemiology, Banganjab, Faculty of Medicine, Ilam University of Medical Scences
City
Ilam
Postal code
Phone
+98 84 1222 7126
Fax
Email
Masoud_1241@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Solimannezhad Kouresh
Position
Cardiologist
Other areas of specialty/work
Street address
City
Postal code
Phone
0098
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)