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Evaluation of the Effect of Empagliflozin on Clinical Echocardiographic Parameters in Patients with Pulmonary Arterial Hypertension Secondary to COPD: A Randomized Clinical Trial

Protocol summary

Study aim
Determining the effect of empagliflozin on clinical parameters, including echocardiographic indices, functional class, systolic blood pressure, blood oxygen saturation, frequency of hospitalizations, and the number of exacerbations in patients with pulmonary hypertension secondary to chronic obstructive pulmonary disease
Design
A phase 2, randomized, controlled clinical trial with parallel-group design, conducted on 72 patients. Randomization was performed using a permuted block method with variable block sizes of 2, 4, and 6.
Settings and conduct
This randomized clinical trial will be conducted on 72 patients with COPD and pulmonary arterial hypertension (PAH) who are referred to Hajar and Kashani hospitals. Participants will be randomly assigned, using a permuted block randomization method, into two groups:Intervention group: Standard treatment (bronchodilators ± inhaled corticosteroids) plus Empagliflozin 10 mg once daily for 12 weeks.Control group: Standard treatment only.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Written informed consent to participate in the study, Age over 18 years, Diagnosis of pulmonary hypertension secondary to COPD, Mean pulmonary artery pressure > 20 mmHg, Estimated glomerular filtration rate (eGFR) > 30 mL/min Exclusion Criteria: Active genital infection,Primary (idiopathic) hypertension, Diabetes mellitus, Pre-existing heart failure, Underlying renal failure with serum creatinine ≥ 3 mg/dL, Any hypersensitivity reaction, Angioedema, Acute kidney injury, Ketoacidosis, Urinary tract infection associated with the use of empagliflozin
Intervention groups
Intervention group: Standard treatment + Empagliflozin tablet Control group: Standard treatment
Main outcome variables
Echocardiographic parameters, functional class, systolic blood pressure, blood oxygen saturation, number of hospitalizations, and frequency of disease exacerbations.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250908067192N1
Registration date: 2025-10-07, 1404/07/15
Registration timing: prospective

Last update: 2025-10-07, 1404/07/15
Update count: 0
Registration date
2025-10-07, 1404/07/15
Registrant information
Name
Farank Filsoof
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
faranakfilsoof@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-12, 1404/08/21
Expected recruitment end date
2026-07-11, 1405/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Empagliflozin on Clinical Echocardiographic Parameters in Patients with Pulmonary Arterial Hypertension Secondary to COPD: A Randomized Clinical Trial
Public title
Effect of Empagliflozin on Pulmonary Arterial Hypertension Secondary to COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Mean pulmonary arterial pressure above 20 mmHg Glomerular filtration rate above 30 ml/min Written informed consent to participate in the study Diagnosis of pulmonary arterial hypertension secondary to COPD
Exclusion criteria:
Presence of active genital infection Primary hypertension,Diabetes mellitusUnderlying heart failure, Underlying renal failure with serum creatinine equal to or greater than 3 mg/dL Pregnancy Any allergic reaction, angioedema, acute kidney injury, ketoacidosis, urinary tract infection caused by empagliflozin
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups—intervention (standard treatment + empagliflozin pill) and control (standard treatment)—based on a random permutation method with random block sizes of 4, 2, and 6 (due to the uncertainty of the last individual in each block).
Blinding (investigator's opinion)
Not 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 Shahrekord University of Medical Sciences
Street address
University Headquarters, Kashani Blvd, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Approval date
2025-02-04, 1403/11/16
Ethics committee reference number
IR.SKUMS.MED.REC.1403.115

Health conditions studied

1

Description of health condition studied
Pulmonary hypertension secondary to chronic obstructive pulmonary disease
ICD-10 code
I27.9
ICD-10 code description
Pulmonary heart disease, unspecified

Primary outcomes

1

Description
Mean echocardiographic parameters (cardiac output, mean pulmonary artery pressure, pulmonary artery pressure, right ventricular systolic pressure, right ventricular function, pulmonary vascular resistance, cardiac index)
Timepoint
Before the intervention and after taking empagliflozin
Method of measurement
Echocardiography device

2

Description
Frequency of pulmonary hypertension activity class
Timepoint
Before the intervention and after taking empagliflozin
Method of measurement
Questionnaire

3

Description
Mean systolic blood pressure
Timepoint
Before the intervention and after taking empagliflozin
Method of measurement
Mercury sphygmomanometer

4

Description
Mean blood oxygen saturation
Timepoint
Before the intervention and after taking empagliflozin
Method of measurement
Pulse oximetry device

Secondary outcomes

1

Description
Number of hospitalizations
Timepoint
After administration of empagliflozin
Method of measurement
Checklist

2

Description
Frequency of COPD exacerbations
Timepoint
After administration of empagliflozin
Method of measurement
Checklist

Intervention groups

1

Description
Intervention group: Standard treatment (Flosalmax inhaler, two puffs every 12 hours; manufactured by Jaber Pharmaceutical Company) plus Empagliflozin 10 mg tablet (manufactured by Abidi Pharmaceutical Company), once daily for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Standard treatment (Flosalmax inhaler, two puffs every 12 hours; manufactured by Jaber Pharmaceutical Company)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Zahra Habibi
Street address
Hajar Hospital, Parsart Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Fax
Email
faranakfilsoof@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Akbar Soleimani Babadi
Street address
University Headquarters, Kashani Blvd,Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881685433
Phone
+98 38 3222 0016
Fax
Email
dr.akbarsoleymani@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Habibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parsart Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Fax
Email
habibi.z@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Habibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parsart Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Fax
Email
habibi.z@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Habibi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parsart Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Fax
Email
habibi.z@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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