Determining the effect of dapagliflozin on Brain natriuretic peptide in patients with pulmonary arterial hypertension groups
Design
A controlled, parallel-group, triple-blind, randomized, phase 2 clinical trial on 100 patients. Randomization is done by RIT randomization software.
Settings and conduct
This study is a phase two clinical trial. Pulmonary arterial hypertension patients referring to PH clinic in Masih Daneshvari Hospital after screening according to inclusion and exclusion criteria would be divided into two groups of intervention and control. Data collection form will be fulfilled at baseline and after 3 months. The results will be collected and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age ≥ 18 years
• Diagnosis of group 1 or group 4 PAH
• NYHA functional class above one
Exclusion criteria:
• SGLT2i treatment within 6 months prior to study entry
• eGFR less than 30 ml/min/m2
• Severe liver dysfunction
• Severe urinary or vaginal infection
Intervention groups
Patients are divided into two groups receiving dapagliflozin with a dose of 10 mg daily for 3 months and a control group, including 50 patients in each arm. The intervention group takes one tablet daily for 3 months. The control group takes a placebo pill daily for 3 months.
Main outcome variables
Pro- Brain natriuretic peptide (Pro- BNP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200209046427N2
Registration date:2023-08-18, 1402/05/27
Registration timing:prospective
Last update:2023-08-18, 1402/05/27
Update count:0
Registration date
2023-08-18, 1402/05/27
Registrant information
Name
Shadi Shafaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2522
Email address
shafaghishadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Dapagliflozin on Cardiovascular Outcomes and Quality of Life in Pulmonary Arterial Hypertension Patients
Public title
Dapagliflozin in Pulmonary Arterial Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age > or = 18
PAH, class of 1 & 4 based on guideline
In the case of group 4 PH, the patient should not be candidate for endarterectomy or balloon angioplasty during project
NYHA Functional Class >1
Clinically stable patients on pulmonary vasodilator treatment and treatment duration of at least four weeks. Clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening PAH within three months of screening.
Literacy
Informed consent
Exclusion criteria:
Allergy to SGLT2i
treatment with SGLT2i in last 6 months
PAH 2, 3, 5
eGFR <30
Severe liver dysfunction (Child-Pugh Class C)
Lung transplant candidate
Type 1 diabetes
Severe Urinary or vaginal infection
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is designed to randomize subjects into groups that result in equal sample sizes and to ensure a balance in sample size across groups over time. Patients will be entered into the study groups by simple randomization in a 1:1 ratio (intervention to control ratio) and in blocks of 4. The investigators ensure unpredictability of the allocation sequence and by using a computerized random number generation process. By using this central randomization, the random allocation sequence will remain concealed from those enrolling patients into the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
People involved in the trial including participants(patients), principle investigator particularly investigator initiated trial, healthcare providers (Physicians, nurses, etc.), who care for participants during the trial, data collectors, and outcome assessors and data saftey and monitoring board do not know if the recipient is receiving the actual drug or placebo and all of them are blinded.
Dapagliflozin tablets 10 mg from Actover company in both intervention and placebo groups are completely similar in terms of color, shape, smell, size and method of administration. Drugs will be delivered to patient as A or B in the same shape, and nobody knows which of them is true drug and which of them is placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2023-08-13, 1402/05/22
Ethics committee reference number
IR.SBMU.NRITLD.REC.1402.092
Health conditions studied
1
Description of health condition studied
Pulmonary arterial hypertension
ICD-10 code
I27. 0
ICD-10 code description
Primary pulmonary hypertension
Primary outcomes
1
Description
Pro- Brain natriuretic peptide (Pro-BNP)
Timepoint
First day, 3 months later at the randomization time
Method of measurement
Laboratory data (Blood Sample)
Secondary outcomes
1
Description
The 6-minute walk test (6MWT) test
Timepoint
First day, 3 months later at the randomization time
Method of measurement
Treadmill
2
Description
New York Heart Association (NYHA) functional class
Timepoint
First day, 3 months later at the randomization time
Method of measurement
Taking History approved by physician
3
Description
Health Related Quality of Life
Timepoint
First day, 3 months later at the randomization time
Method of measurement
EmPHasis-10 Health Related Quality of life questionnaire
4
Description
Pulmonary arterial pressure (PAP)
Timepoint
First day, 3 months later at the randomization time
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Shafaghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3810
Fax
+98 21 2610 9484
Email
shafaghishadi@Yahoo.Com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Sharif Kashani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3810
Fax
+98 21 2610 9484
Email
Babaksharifkashani@Yahoo.Com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sima Noorali
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
002127123810
Fax
+98 21 2610 9484
Email
simanoorali@yahoo.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 collected deidentified patient`s documents can be available.
When the data will become available and for how long
Documents files will become available 6 months after publication up to one year
To whom data/document is available
Documents would be available for people working in academic institutions and people working in businesses after applying to receive it.
Under which criteria data/document could be used
Documents would be available according to cause of request.
From where data/document is obtainable
shafaghishadi@yahoo.com
Documents would be available according to cause of request.
Shadi Shafaghi
What processes are involved for a request to access data/document
It is necessary for the applicant to send an e-mail to the researcher and write the reason for requesting access to the data. If confirmed, the information will be sent within a week.