Investigating the effect of inhaled verapamil on pulmonary artery systolic pressure in patients with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital, Tehran: a randomized, double-blind clinical trial
Investigating the effect of inhaled verapamil on pulmonary artery systolic pressure in patients with chronic obstructive pulmonary disease
Design
Patients with chronic obstructive pulmonary disease are divided into 2 drug intervention and control groups
The clinical trial has a total sample size of 46 patients. The randomization method is based on the randomization table designed based on blocks of 4.
Settings and conduct
In the drug receiving group, verapamil was administered by inhalation in the amount of 10 mg with a dilution of 2.5 mg/ml with a volume of 4 cc by the Ultrasonic Nebulier CUN60 device once every 12 hours for 72 hours and a total of 60 mg. In the placebo group, 4 cc of distilled water (DW) was inhaled every 12 hours for 72 hours, then all patients underwent echocardiography one hour after receiving the last dose.
The doctor treating the patient knows how to intervene in patients, but the echocardiologist colleague and the colleague responsible for recording clinical information and echo parameters do not know about the intervention.
Participants/Inclusion and exclusion criteria
Patients with chronic obstructive pulmonary disease and hospitalized in Imam Khomeini Hospital
No history of kidney failure, liver failure, pulmonary embolism and congenital heart disease
Intervention groups
Patients with COPD were selected based on GOLD clinical criteria, spirometric characteristics, and the presence of clinical symptoms. Then the patients are divided into two groups receiving inhaled verapamil and placebo.
Main outcome variables
pulmonary artery pressure; EF value; RV size; TAPSE; RVsm; RV FAC; Mean PAP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230804059027N1
Registration date:2023-08-12, 1402/05/21
Registration timing:registered_while_recruiting
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Kazem Gharloghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4822 7603
Email address
dr.k.gharloghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-07, 1402/05/16
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of inhaled verapamil on pulmonary artery systolic pressure in patients with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital, Tehran: a randomized, double-blind clinical trial
Public title
Investigating the effect of inhaled verapamil on pulmonary artery systolic pressure in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with proven chronic obstructive pulmonary disease based on spirometry criteria and patient history
Patients with proven chronic obstructive pulmonary disease and hospitalized in Imam Khomeini Hospital
Exclusion criteria:
Valvular heart disease more than moderate
Pulmonary valve stenosis
History of renal failure
History of liver cirrhosis
History of pulmonary embolism
Congenital heart disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups receiving inhaled verapamil and placebo. The method of randomization is based on the randomization table designed on the basis of blocks of 4, so that the patient's doctor knows how to intervene in patients, but the echocardiologist colleague and the colleague responsible for recording clinical information and echo parameters do not know about the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients with COPD are selected based on GOLD clinical criteria, spirometric characteristics, and the presence of clinical symptoms by respected professors specializing in pulmonary diseases. Then the patients are divided into two groups receiving inhaled verapamil and placebo. The method of randomization is based on the randomization table designed on the basis of blocks of 4, so that the attending physician (clinical caregiver) knows how to intervene in patients, but the echocardiologist colleague and the colleague responsible for recording clinical information and echo parameters as well The co-analysts of the data are not aware of the clinical intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran Uninersity of Medical Sciences
Street address
Imam Khomeini Hospital., Doctor Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.214
Health conditions studied
1
Description of health condition studied
chronic obsrtuctive pulmonary disease
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
Pulmonary artery systolic pressure reduction
Timepoint
Pulmonary artery systolic pressure was measured by echocardiography at the beginning of the study (before the intervention) and 1 hour after receiving inhaled verapamil.
Method of measurement
Echocardiography device Affiniti 50
Secondary outcomes
1
Description
The increase in oxygen saturation of arterial blood
Timepoint
Arterial blood oxygen saturation is measured before receiving inhaled verapamil (pre-intervention) and 1 hour after the intervention.
Method of measurement
Measurement of arterial blood oxygen saturation is done by finger pulse oximeter
Intervention groups
1
Description
Intervention In the intervention group: with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital in this group, verapamil in the form of inhalation and in the amount of 10 mg with a dilution of 2.5 mg/mL with a volume of 4 cc by Ultrasonic Nebulier CUN60 device once every 12 hours for 72 hours and in A total of 60 mg is prescribed.
Category
Treatment - Drugs
2
Description
Control group: In the control group: patients with chronic obstructive pulmonary disease hospitalized in Imam Khomeini Hospital, distilled water (placebo) was administered by inhalation in the amount of 4cc by Ultrasonic Nebulier CUN60 every 12 hours for 72 hours and a total of 24cc. .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital (RA)
Full name of responsible person
Dr. Akram Sardari
Street address
Imam Khomeini Hospital., Doctor Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2762
Email
sardaricardio@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akram Sardari
Street address
Imam Khomeini Hospital., Doctor Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2762
Email
sardaricardio@gmail.com
Grant name
Research assistant of Tehran University of Medical Sciences
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Kazem Gharloghi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Imam Khomeini Hospital., Doctor Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2762
Email
Dr.K.Gharloghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Sardari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Khomeini Hospital., Doctor Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2762
Email
sardaricardio@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Sardari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Khomeini Hospital., Doctor Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2762
Email
sardaricardio@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after de-identifying individuals.
The specific title of the documentation is the relationship between inhaled verapamil and pulmonary artery pressure in COPD patients .
When the data will become available and for how long
The access period starts one year after the results are published.
To whom data/document is available
It is possible to access the data for all researchers working in academic and scientific institutions as well as people working in the industry.
Under which criteria data/document could be used
There are no other conditions and restrictions for the use of data.
From where data/document is obtainable
Visiting the library of Imam Khomeini Hospital and the library of the Faculty of Medicine of Tehran University of Medical Sciences.
Email address :
1- sardaricardio@gmail.com
2- Dr.K.Gharloghi@gmail.com
What processes are involved for a request to access data/document
The applicant can access the data files by providing valid documents for scientific research or industry-related work.