Protocol summary

Summary
Chronic obstructive pulmonary disease is the fourth leading cause of death in the world and more than ten million people caught the disease in America. Due to the importance of chronic obstructive pulmonary disease in public health around the world, we aimed to investigate The effects of statins on pulmonary artery pressure in the patients with chronic obstructive pulmonary disease. This triple blind, randomized control trials will perform on 21 COPD patients with atorvastatin treatment and 21 COPD patients without receiving any treatment who attended to Vali-Asr hospital, Birjand, East of Iran 2016. Inclusion criteria were as follow: no previous use of statins, Performing CBC, lipid profile, LTF, absence of liver disease, FEV1<80% and FEV1/FVC<70%. Also, patients excluded for the following reasons: discontinuation of statin therapy during the study, having advanced heart disease, the advent of statin therapy complications, long-term use of corticosteroid and death. Both groups will tested with echocardiography for presence of pulmonary hypertension by a cardiologist before taking atorvastatin and their pulmonary artery pressure will measured at baseline. In addition, Spirometry will perform in both groups. Case group receive 40mg statins per day for six month (24 weeks). At the end of this study, patients evaluate by spirometry and echocardiography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042527594N1
Registration date: 2016-06-26, 1395/04/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-26, 1395/04/06
Registrant information
Name
Morteza Hajihosseini
Name of organization / entity
Birjand University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 625 0645
Email address
m.hajihosseini@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-05-15, 1395/02/26
Expected recruitment end date
2016-11-15, 1395/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of The effects of statins on pulmonary artery pressure in the patients with chronic obstructive pulmonary disease
Public title
Effects of statins on pulmonary artery pressure in the patients with chronic obstructive pulmonary disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: no previous use of statins; Performing CBC; lipid profile; LTF; absence of liver disease; FEV1<80%; FEV1/FVC<70%. Exclusion criteria: discontinuation of statin therapy during the study; having advanced heart disease; the advent of statin therapy complications; long-term use of corticosteroid; death
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical sciences
Street address
Birjand University of Medical sciences, Ayatollah Ghafari ST, Birjand
City
Birjand
Postal code
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
03111393

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44
ICD-10 code description
Chronic obstructive pulmonary disease

Primary outcomes

1

Description
Pulmonary Artery Pressure changes
Timepoint
Befor and After drug use
Method of measurement
Echocadiography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving statin 40 miligram per day for six month
Category
Treatment - Drugs

2

Description
Control group: Receiving nothing
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Anahita Aryan
Street address
Valiasr Hospital, Ayatollah Ghafari ST, Birjand
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical sciences
Full name of responsible person
Gholamreza Sharifzade
Street address
Birjand University of Medical sciences, Ayatollah Ghafari ST, Birjand
City
Birjand
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, Birjand 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
Birjand University of Medical sciences
Full name of responsible person
Anahita Aryan
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Birjand University of Medical sciences, Ayatollah Ghafari ST, Birjand
City
Birjand
Postal code
Phone
+98 56 3244 3000
Fax
Email
dr.arian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Toba Kazemi
Position
MD
Other areas of specialty/work
Street address
Valiasr Hospital, Ayatollah Ghafari ST, Birjand
City
Birjand
Postal code
Phone
+98 56 3244 3000
Fax
Email
drtooba.kazemi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical sciences
Full name of responsible person
Morteza Hajihosseini
Position
MSc
Other areas of specialty/work
Street address
Birjand University of Medical sciences, Ayatollah Ghafari ST, Birjand
City
Birjand
Postal code
Phone
+98 56 3244 3000
Fax
Email
mortezahaji87@gmail.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
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