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Evaluation of the effect of atorvastatin on the treatment of secondary pulmonary hypertension due to chronic obstructive air way diseases

Protocol summary

Summary
Aim: The assessment of therapeutic effects of atorvastatin in patients with pulmonary arterial hypertension (PAH) due to chronic obstructive pulmonary disease (COPD). This study is a triple randomized controlled trial, unicenter that patients with secondary pulmonary hypertension due to COPD who are reffered to Rasoul Akram hospital and they have 18-80 years old, systolic pulmonary arterial hypertension (SPAP)>40mmhg, LDL>70mg/dl, ALT and AST<3 times upper limit normal, no drug history of prostanoids, statins, endothelin antagonists and phosphodiesterases, able to doing 6-min walk test and obstructive pattern in spirometry are selected and randomized in two groups. Our pretreatment evaluations include CRP, Spirometry, Echocardiography, patients` signs and symptoms, and then they are randomized to receive either atorvastatin 40 mg/d or placebo in addition to current treatment for 6 months. The primary outcome is SPAP at 6 months after randomization and secondary outcomes include cardiac output (CO), right ventricular size, CRP, 6 min walk distance test, spirometry parameters and changes in signs and symptoms. Finally, primary and secondary outcomes will be evaluated after six months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108257411N1
Registration date: 2012-05-20, 1391/02/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-20, 1391/02/31
Registrant information
Name
Hanieh Raji
Name of organization / entity
Imam Khomeini hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6501
Email address
raji-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of atorvastatin on the treatment of secondary pulmonary hypertension due to chronic obstructive air way diseases
Public title
The effect of atorvastatin on the treatment of secondary pulmonary hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Systolic pulmonary hypertension>40mmhg; age 18 years or over until 80; no drug history of prostanoids, statins, endothelin antagonists and phosphodiesterase; able to doing 6-min walk test; obstructive pattern in PFT and functional class 2,3 (NYHA). Exclusion criteria: PAH from a cause other COPD; LDL<70 mg/dl; ALT or AST> 3x ULN.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Tehran university of medical sciences
Street address
Hemmat high way, Pardis e Hemmat,Tehran university of medical sciences
City
Tehran
Postal code
Approval date
2009-05-14, 1388/02/24
Ethics committee reference number
310/90-116

Health conditions studied

1

Description of health condition studied
secondary pulmonary hypertension
ICD-10 code
J40-J47
ICD-10 code description
Chronic lower respiratory diseases

Primary outcomes

1

Description
Systolic pulmonary hypertension
Timepoint
At the beginning of study and 6 months later
Method of measurement
Echocardiography

Secondary outcomes

1

Description
CRP
Timepoint
At the beginning of study and 6 months later
Method of measurement
Lab data

2

Description
Cardiac output
Timepoint
At the beginning of study and 6 months later
Method of measurement
Echocardiography

3

Description
Right ventricular size
Timepoint
At the beginning of study and 6 months later
Method of measurement
Echocardiography

4

Description
6 min walk test
Timepoint
At the beginning of study and 6 months later
Method of measurement
By researcher

5

Description
FEV1, FVC, FEV1/FVC
Timepoint
At the beginning of study and 6 months later
Method of measurement
Spirometry

6

Description
Adverse effect of drug
Timepoint
One month after beginning and the end of treatment
Method of measurement
By lab data and symptoms

Intervention groups

1

Description
Tab atorvastatin 20 mg BID (twice a day) in case group
Category
Treatment - Drugs

2

Description
placebo in control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Tehran university of medical sciences, Hemmat Pardis
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university of medical sciences
Full name of responsible person
Dr. Seied Alijavad Moosavi
Position
Pulmonologist
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niaiesh street, Sattarkhan
City
Tehran
Postal code
Phone
+98 21 4465 9771
Fax
Email
Dr_moosavi_pul@yahoo.ca
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Seied Alijavad Moosavi
Position
Pulmonologist
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niaiesh Street, Sattarkhan
City
Tehran
Postal code
Phone
+98 21 4465 9771
Fax
Email
dr_moosavi_pul@yahoo.ca
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Hanieh Raji
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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