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Empagliflozin Effect in Pulmonary hypertension

Empagliflozin Effects on Pulmonary Artery Pressure in Patients With pulmonary hypertension

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241014063361N1
Enrollment
64
Registered
2024-10-16
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

pulmonary hypertension. Primary pulmonary hypertension , other secondary pulmonary hypertension

Interventions

Intervention 1: Intervention group: Empagliflozin 10 mg tablets produced by Dr. Abidi Pharmaceuticals were given once a day for 3 months. Intervention 2: Control group: Placebo with the same color, sh

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age>18 years PH diagnosis with (sPAP>20) in echocardiograghy LVEF>50% in echo for rule out of LHF steady state of pulmonary hypertension treatment with standard of care(SOC) therapies for at least 1 agent from a list including an endothelin antagonist (ERA), a phosphodiesterase inhibitor (5 PDES), a soluble guanylate cyclase stimulator or a prostacyclin analoge or receptor agonist(SC/inhaled/PO) refers.

Exclusion criteria

Exclusion criteria: left heart failure(LHF) (the second group of PH) severe liver failure or cirrhosis or active liver disease(liver enzymes more than 3 times higher fromthe upper range of lab glomerular filtration rate less than 20 mg/min per 1.73 square meters of body surface according to CKD-EPI formola pregnant or breastfeeding women lack of drug compliance or allergy no gliflozin or corton or lithium use history of persistent urinary tract infection ( twice in the last 6 months)

Design outcomes

Primary

MeasureTime frame
Percentage of people who have high pulmonary blood pressure (diagnosis of blood pressure in echo with PAP>30). Timepoint: Measurement of pulmonary artery pressure at the beginning of the study (before the start of the intervention) and 90 days after the start of empagliflozin. Method of measurement: Echocardiography parameters.;The percentage of people with high pulmonary pressure who have a low walking rate. Timepoint: Measurement at the beginning of the study (before the start of the intervention) and 90 days after the start of empagliflozin. Method of measurement: 6 minute walk distance.;Percentage of people with high pulmonary pressure who have high BNP test. Timepoint: Measurement at the beginning of the study (before the start of the intervention) and 90 days after the start of empagliflozin. Method of measurement: Lab test.

Secondary

MeasureTime frame
6-minute walk improvement. Timepoint: Comparison of the amount of walking at the beginning of the study (before the start of the intervention) and 90 days after the start of taking the drug. Method of measurement: meter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHedayat Valimanesh

Bagheiat-allah University of Medical Sciences

Hed.valimanesh@gmail.com+98 21 8805 0435

Outcome results

None listed

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