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Empagliflozin in Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

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Empagliflozin in Pulmonary Arterial Hypertension

Feasibility Study of Empagliflozin As Treatment for Idiopathic Pulmonary Arterial Hypertension

NCT05493371•Amsterdam UMC, location VUmc

Summary

The aim of the study is to determine whether conducting a randomized placebo-controlled clinical trial is feasible, safe for the patient and whether the treatment is well tolerated in patients with idiopathic pulmonary arterial hypertension.

Detailed Description

This study is designed as a prospective, single-center, phase IIa, single-arm, open-label, interventional proof-of-concept trial in patients diagnosed with idiopathic pulmonary arterial hypertension (IPAH) who are currently on stable therapy. Patients will be administered a once-daily oral dose of 10 mg empagliflozin for a duration of 12 weeks along with standard treatment. The primary objective of this study is to assess safety and tolerability of empagliflozin and to assess whether a potential future randomized, double-blind, placebo-controlled study is feasible.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. Diagnosis of idiopathic PAH
•3. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH with subtype idiopathic PAH. The documented RHC shows all of the following criteria:
•1. mPAP \> 20 mmHg at rest
•2. Pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg at rest
•3. PVR ≥ 240 dyn·sec/cm5 (3 Wood units) at rest
•4. Symptomatic pulmonary hypertension classified as World Health Organization (WHO) functional class (FC) II, III or IV
•5. PAH therapy is at stable (per investigator) dose levels of standard of care (SoC) therapies for at least 90 days prior screening. SoC therapy refers to a therapy consisting of at least 1 agent from a list including: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist (SC/inhaled/PO).

Exclusion Criteria

•1. Any subject who received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study. Patients participating in a purely observational trial will not be excluded
•2. Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 months), unable or unwillingly to either:
•1. Use highly effective methods of birth control according to the International Conference on harmonisation of pharmaceuticals for human use (ICH) that result in a low failure rate of less than 1% per year when used consistently and correctly 43. Highly effective methods include hormonal contraception (for example, birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (having your tubes tied); or a partner with a vasectomy who has completed follow-up to confirm a successful procedure
•2. Have a negative pregnancy tests as verified by the investigator prior to starting study therapy and agrees to have an extra pregnancy test 8 weeks after start of the study
•3. Contraindication for CMR imaging as defined in the protocol of the Amsterdam UMC "Kwaliteitsdocument Cardiale MRI (Versie 1)". The list of contra-indications includes: claustrophobia, ferromagnetic implants, implanted cardioverter defibrillator (ICD) or pacemaker (except for the MR conditional) and ball-in-cage mechanic heart valve.
•4. Impaired renal function, defined as eGFR \< 30 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis
•5. History of chronic severe (Child Pugh classification score \>10, Appendix 1) or active liver disease defined as serums transaminases \>5 x upper limit of normal (ULN) or bilirubin \> 1.5 x ULN
•6. History of ketoacidosis
•7. Known allergy, intolerance or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
•8. Use of lithium compounds and being unable or unwillingly to increase the monitoring frequency of lithium levels
+13 more criteria

Locations (1)

Amsterdam UMC, location Vumc

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

March 1, 2023

Primary Completion Date

November 1, 2024

Completion Date

November 1, 2024

Last Updated

November 20, 2024

Enrollment

ACTUAL participants

Conditions

Idiopathic Pulmonary Arterial Hypertension

Interventions

Empagliflozin 10 MG

DRUG

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WITHDRAWNNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Empagliflozin in Pulmonary Arterial Hypertension

Inclusion Criteria

Exclusion Criteria

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