Effect of combined selenium and Coenzyme Q10 on left ventricular function and functional capacity in patients with heart failure (left ventricular dysfunction)
According to Low cardiac contents of selenium and coenzyme Q10 in patients with heart failure; The aim of this study is to evaluate the vital relationship between two substances to obtain optimal function of the myocardium. Inclusion criteria are male and female patients with ischemic or nonischemic heart failure with LVEF less than 50% and NYHA CLASS 2, 3 white no change in their previous medical treatment and no revascularization Procedure during the last month. Exclusion criteria are the patient whom experienced acute coronary syndrome in the Course of the study or have any change in medical treatment or have any revascularization Procedure during the study.the patient white severs renal or hepatic or respiratory failure are excluded.3 month randomized double-blind placebo-controlled trial among Iranian citizens aged 30 to 85 will perform in 64 participants given combined supplementation of 200mcg selenium and 90mg coenzyme Q10 per day or a placebo. Clinical examinations NYHA functional capacity classification and echocardiography white simpson method will perform before and after intervention. Participants were monitored every 1th month throughout the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020512371N1
Registration date:2013-10-28, 1392/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-28, 1392/08/06
Registrant information
Name
Parvin Bahrami
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44223250311
Email address
p_bahrami.2010@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences and CO Q10 is Sponsored by eksir Company
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined selenium and Coenzyme Q10 on left ventricular function and functional capacity in patients with heart failure (left ventricular dysfunction)
Public title
Effect of combined selenium and Coenzyme Q10 on heart failure treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male and female with ischemic and nonischemic heart failure; aged between 30 to 85 years old; LVEF less than 50% (with simpson method);NYHA CLASS 2,3; stability for 1month with no change in dose and kind of drugs in at least one month perior.
Exclusion criteria: ACS or Revascularization procedure in 1month before or during study;heart failure with killip class 3, 4; active Myocarditis and pricarditis; uncontroled HTN; severe renal dysfunction (GFR less than 30%); pulmonary dysfunction( PCO2 more than 45 and Po2 less than 60); liver dysfunction(CHILD 2,3).
Age
From 35 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Azadi Square, Isfahan
City
Isfahan
Postal code
Approval date
2012-08-22, 1391/06/01
Ethics committee reference number
392080
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure
2
Description of health condition studied
Heart failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
EF (Simpson)
Timepoint
before intervention- after 3 month inetrvention
Method of measurement
echocardiography
2
Description
functional calss with NYHAN CLASS
Timepoint
BEFORE INTERVENTION-3MONTH LATER
Method of measurement
questionair
Secondary outcomes
1
Description
Gastrointestinal symptoms/diarrhea
Timepoint
at the end of each mounth
Method of measurement
interview
2
Description
echocardiography parameter (LVEF Mmode, EDD, ESD)
Timepoint
after and before intervention
Method of measurement
echocardiography
3
Description
skin rash
Timepoint
each month
Method of measurement
inteview
Intervention groups
1
Description
intervention group: co Q10 30 mg TID
selenium 200 mcg OD
Category
Treatment - Drugs
2
Description
control group: 2kind of Placebo as form of co q10 and selenium
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Cardiovascular disease Dr Mohammad Grakyaraghi
Full name of responsible person
Dr Mohammad Grakyaraghi
Street address
Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Dr Parvin Bahrami
Street address
Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Research Department of Isfahan University
Full name of responsible person
Dr Mirali Mohammad Sabz Ghabaii
Street address
Azadi Square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Research Department of Isfahan University
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Exir Pharmaceutical Companies
Full name of responsible person
Dr Noshin Chitsaz
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Pharmaceutical Companies
Proportion provided by this source
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Parvin Bahrami
Position
Cardiovascular Resident
Other areas of specialty/work
Street address
Cardiovascular Research Center of Isfahan University
City
Isfahan
Postal code
Phone
+98 31 1212 3413
Fax
Email
p_bahrami.2010@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Garakyaraghi
Position
Cardiovascular Attending Physicians, Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Azadi Square, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1237 8578
Fax
Email
mgy466@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Parvin Bahrami
Position
Cardiovascular Resident
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Azadi Square, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1212 3413
Fax
Email
p_bahrami.2010@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)