Protocol summary

Summary
objective:The effect of atorvastatin on the level of inflammatory marker and right ventricular function in chronic obstructive pulmonary disease patients design:study groups: chronic obstructive pulmonary disease patients; third phase, sample size: 50; blinding: double blind; randomization: randomized; single center. Setting and conduct: for evaluating the right ventricle we used longitudinal systolic strain / strain rate echocardiography. Participants including major eligibility criteria: having stable chronic obstructive pulmonary disease for at least 3 month. Intervention: giving 40 milligram atorvastatin to 25 patients and placebo to other group main outcome measures (primary and secondary outcome variables): right ventricular size; pulmonary artery pressure; level of high sensitive C reactive protein

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108177356N1
Registration date: 2015-09-21, 1394/06/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-21, 1394/06/30
Registrant information
Name
Hoorak Poorzand
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2753
Email address
poorzandh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2013-03-18, 1391/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of atorvastatin on the level of high sensitive C reactive protein and right ventricular function in chronic obstructive pulmonary disease patients
Public title
The effect of atorvastatin on the level of inflammatory marker and right ventricular function in chronic obstructive pulmonary disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: having stable chronic obstructive pulmonary disease for at least 3 month exclusion criteria: having coronary artery disease, using medication for reducing lipid profile; having atrial fibrilation rhythm; having active liver disease; having active infection; having malignancy; having connective tissue diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Number 30, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUMS.REC.1389.81

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
ICD-10-CM
ICD-10 code description
بیماری انسدادی مزمن ریه،غيرمشخص قابل تعميم به بیماری انسدادی مزمن راه هوايي غيراختصاصي يا بیماری انسدادی مزمن ریه غيراختصاصي

Primary outcomes

1

Description
right ventricle systolic function
Timepoint
3 months after intervention
Method of measurement
tissue duppler and speckle tracking echocardiography

Secondary outcomes

1

Description
High sensitive C reactive protein
Timepoint
3 months after intervention
Method of measurement
blood sample

Intervention groups

1

Description
atorvastatin abidi company, 40 milligram, once a day, 3 month
Category
Treatment - Drugs

2

Description
placebo abidi company, 40 milligram, once a day, 3 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
cardiology ward of Imam Reza hospital
Full name of responsible person
Hoorak Poorzand
Street address
Mashhad- Doctora street- Imam Reza square- cardiology ward of Imam Reza hospital
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Hoorak Poorzand
Street address
Mashhad University of Medical Sciences, Azadi squre, Mashhad
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoorak Poorzand
Position
Assistant proffesor of cardiology. Echocardiologist
Other areas of specialty/work
Street address
Cardiology ward, Imam Reza hospital, Imam Reaza square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3763 6933
Fax
Email
poorzandh@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoorak Poorzand
Position
Assistant proffesor of cardiology. Echocardiologist
Other areas of specialty/work
Street address
Cardiology ward, Imam Reza hospital, Imam Reaza square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3763 6933
Fax
Email
poorzandh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoorak Poorzand
Position
Assistant proffesor of cardiology. Echocardiologist
Other areas of specialty/work
Street address
Cardiology ward, Imam Reza hospital, Imam Reaza square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3763 6933
Fax
Email
poorzandh@mums.ac.ir
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
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