The aim of this double blind controlled clinical trial is to evaluate of Atorvastatin effect on Pulmonary Arterial pressure (PAP) in patients with chronic obstructive pulmonary disease (COPD). In this study 70 patients with COPD (based on spirometric criteria) and PAP>25mm Hg will randomly (odd numbers for intervention group and even numbers for control) divided into two groups (n=35); intervention (cap atorvastatin, 40mg/day for 3 months) and control (cap placebo, 1 cap/day for 3 months). Patients and responsible physicians will be blind. Demographic data, the results of right ventricle (RV) echocardiographic study (RV size and ejection fraction) and the results of 6 minute walk test (systolic and diastolic blood pressure and o2 saturation before and after of the test and total distance) prior to intervention and 3 months later will compared between two groups. The history of allergy to atorvastatin, cardiac diseases, stroke in recent 3 months and COPD exacerbation are exclusion criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051213299N1
Registration date:2013-06-27, 1392/04/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-27, 1392/04/06
Registrant information
Name
Ali Cheraghi
Name of organization / entity
Arak University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 2004
Email address
dralicheraghi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Arak University of Medical Sciences.
Expected recruitment start date
2013-08-01, 1392/05/10
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of atorvastatin effects with placebo on pulmonary pressure in COPD patients
Public title
Atorvastatin and Pulmonary Pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Resting pulmonary blood pressure>25mmHg; functional class II, III; ability of take part in 6 min walk test.
Exclusion criteria: Cardiac diseases, Systolic blood pressure>180mmHg, Diastolic blood pressure>100mmHg, Heart rate>120/min; heart failure (LVEF<50%); no compliance, history of allergy to atorvastatin, COPD exacerbation; stroke in recent 3 months.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht Sq., Arak.
City
Arak
Postal code
Approval date
2012-05-30, 1391/03/10
Ethics committee reference number
91-127-5
Health conditions studied
1
Description of health condition studied
COPD
ICD-10 code
J44
ICD-10 code description
Chronic lower respiratory diseases
2
Description of health condition studied
Pulmonary hypertension
ICD-10 code
I27.9
ICD-10 code description
Pulmonary heart disease, unspecified
Primary outcomes
1
Description
Pulmonary Artery Blood Pressure
Timepoint
before and 3 months after intervention
Method of measurement
Echocardiographic study
2
Description
Right ventricle ejection fraction
Timepoint
Before intervention and 3 months later
Method of measurement
TAPSE in Echocardiographic study
3
Description
Systolic Blood Pressure
Timepoint
Before and after 6 minute walk test, before and 3 months after intervention
Method of measurement
mmHg, Mercury barometer
4
Description
Diastolic Blood Pressure
Timepoint
before and after of 6 minute walk test, before and 3 months after intervention
Method of measurement
mmHg, Mercury barometer
5
Description
Heart Rate
Timepoint
before and after 6 minute walk test, before and 3 months after intervention
Method of measurement
Rate/ Minute
6
Description
Total distance in 6MWT
Timepoint
before and 3 months after intervention
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cap Atorvastatin, 40 mg/day, for 3 months
Category
Treatment - Drugs
2
Description
Control group: Atorvastatin like placebo cap , 1cap/day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Almomenin Hospital
Full name of responsible person
Ali Cheraghi
Street address
Internal ward, Amir Almomenin Hospital, Sardasht sq., Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Saeed Changizi Ashtyani
Street address
Arak, Sardasht sq., Arak University of Medical Sciences
City
Arak
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 Arak 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
Arak University of Medical Sciences.
Full name of responsible person
Ali Cheraghi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Amir Almomenin Hospital, Arak University of Medical Sciences, Sardasht Sq.,Arak
City
Arak
Postal code
Phone
+98 86 1417 3517
Fax
Email
dralicheraghi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Latif Moeini
Position
Sub Specialist of Lung Diseases
Other areas of specialty/work
Street address
Vali Asr Hospital, Vali Asr Sq., Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1222 2004
Fax
Email
dralicheraghi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Cheraghi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Amir Almomenin Hospital, Sardasht Sq., Arak
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)