Effect of Empagliflozin on Pulmonary Arterial Hypertension Secondary to COPD

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250908067192N1

Enrollment

Registered

2025-10-07

Start date

2025-11-12

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension secondary to chronic obstructive pulmonary disease. Pulmonary heart disease, unspecified

Interventions

Intervention 1: 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. Intervention 2: Control group: Standard treatment

manufactured by Jaber Pharmaceutical Company).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;Frequency of pulmonary hypertension activity class. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Questionnaire.;Mean systolic blood pressure. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Mercury sphygmomanometer.;Mean blood oxygen saturation. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Pulse oximetry device.	—

Measure

Time frame

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.;Frequency of pulmonary hypertension activity class. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Questionnaire.;Mean systolic blood pressure. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Mercury sphygmomanometer.;Mean blood oxygen saturation. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Pulse oximetry device.

—

Secondary

Measure	Time frame
Number of hospitalizations. Timepoint: After administration of empagliflozin. Method of measurement: Checklist.;Frequency of COPD exacerbations. Timepoint: After administration of empagliflozin. Method of measurement: Checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Habibi

Shahroud University of Medical Sciences

habibi.z@skums.ac.ir+98 38 3222 0016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026