Comparison of the effectiveness of statins vs placebo on vascular endothelial function in patients with diastolic heart failure and normal coronary angiography
The aim of this study is evaluation of Statin on vascular endothelial function in patients with diastolic heart failure and comparison of Flow Mediated Dilation with sonoraphy (FMD) change in statin and placebo groups. Inclusion criteria are age above 18 years old;diastolic heart failure;normal coronary angiography and exclusion criteria are contraindication to statin therapy and absolute indication for statin therapy.
The Study population include patients with diastolic heart failure according to Echocardiography without history or physical exam findings in favor to ischemic heart disease referred to echocardiography clinic of Imam and Golestan hospitals.
the sample volume needed for intervention and placebo groups calculated 20 and in total 40.in intervention group each patient takes atorvastatin 20 mg daily and control group takes placebo for 8 weeks. At the ends of 8 weeks FMD change for each patient of both groups Will be measured and results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010320538N1
Registration date:2015-06-15, 1394/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Ali Kardooni
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3161
Email address
kardooni.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences/School of Medicine
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-04-04, 1394/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of statins vs placebo on vascular endothelial function in patients with diastolic heart failure and normal coronary angiography
Public title
Evaluation of the effect of Statin on patient with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age above 18y/o: diastolic heart failure;normal coronary angiography
Exclusion criteria
contraindication to statin therapy; indication for statin therapy according to 2013 AHA guideline for lipid management.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences ...
Street address
Golestan boluvared
City
Ahvaz
Postal code
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
AJUMS.REC.1393.414
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
Flow mediated diameter of brachial artery
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Sonography test/Millimeters
Secondary outcomes
1
Description
Lipid profile
Timepoint
Aftetr 8 week treatmnet
Method of measurement
Blood sample/ Mg/dl
Intervention groups
1
Description
In control group 8 weeks treatment with placebo
Category
Treatment - Drugs
2
Description
In intervention group 8 weeks treatment with atorvastatin 20 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Ali kardooni
Street address
Azadegan st, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Atherosclerosis Research Center
Full name of responsible person
Ataollah Ghadiri
Street address
Golestan hospital, Golestan st.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Atherosclerosis Research Center
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
Ahvaz Jundishapur University of Medical Sciences ...
Full name of responsible person
Ali Kardooni
Position
Cardiology Resident
Other areas of specialty/work
Street address
no 76, Hojjat st., zeytoon karmandi
City
Ahwaz
Postal code
Phone
00
Fax
Email
DRALIKA1982@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences ...
Full name of responsible person
Saeed Yazdankhah
Position
Cardiology Attendancy
Other areas of specialty/work
Street address
Azadegan St, Imam khomeini hospital
City
Ahwaz
Postal code
Phone
00
Fax
Email
yazdankhahsaeed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Kardooni
Position
Cardiology Residency
Other areas of specialty/work
Street address
no 76, Hojjat st., zeytoon karmandi
City
Ahwaz
Postal code
6163933811
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)