A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension

China National Center for Cardiovascular Diseases1 site in 1 country72 target enrollmentOctober 20, 2024

ConditionsPulmonary Arterial Hypertension

Interventionsplacebo in treatment pulmonary aerterial hypertension empagliflozin in treatment pulmonary aerterial hypertension

Drugsempagliflozin in treatment pulmonary aerterial hypertension placebo in treatment pulmonary aerterial hypertension

Overview

Phase: Phase 1
Intervention: placebo in treatment pulmonary aerterial hypertension
Conditions: Pulmonary Arterial Hypertension
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 72
Locations: 1
Primary Endpoint: 6-minute walking distance
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn if empagliflozin works to treat patients with pulmonary arterial hypertension. It will also learn about the safety of empagliflozin. The main questions it aims to answer are:

Based on standard treatment, does empagliflozin reduce pulmonary artery pressure and improve cardiac function in patients with pulmonary arterial hypertension? What medical problems do participants have when taking empagliflozin? Researchers will compare empagliflozin to a placebo (a look-alike substance that contains no drug) to see if empagliflozin works to treat patients with pulmonary arterial hypertension.

Participants will:

Take empagliflozin or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the drug taking situation

Registry

clinicaltrials.gov

Start Date

October 20, 2024

End Date

December 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years old.
•Sign the informed consent form.
•Subjects who are willing and able to comply with the requirements of prescribed visits, treatment plans, laboratory examinations and other research procedures.
•PAH with symptoms was initially diagnosed and belonged to one of the following subgroups:
•A. Idiopathic pulmonary hypertension (IPAH); B. hereditary pulmonary hypertension (HPAH); C drug or toxin-induced PAH, based on previous exposure to drugs, chemicals or toxins, such as fenfluramine derivatives, other appetite suppressants, toxic rapeseed oil or L- tryptophan.
•D. PAH is accompanied by:
•A) connective tissue disease B) Congenital systemic-pulmonary shunt (surgical correction must be performed at least one year before screening, and there is no or no clinically insignificant systemic-pulmonary shunt \[1.0≤ lung-systemic blood flow ratio (QP/QS)≤1.5\]), according to the opinion of the researcher.
•Received right heart catheterization (RHC) at the time of screening or within 5 years before screening (if RHC is not performed, it will be performed during screening), which is consistent with the diagnosis of PAH and meets all the following criteria:
•A. mean pulmonary artery pressure (papm) \> 20mmhg (at rest) B pulmonary arteriole wedge pressure (PAWP)≤15 mmHg (if reliable PAWP data cannot be obtained, left ventricular end diastolic pressure \[LVEDP\]≤15 mmHg).
•C pulmonary vascular resistance (PVR) \> 2.00 wood units (\> 160 dynes/sec/cm5).

Exclusion Criteria

•1\) Subjects shall not have the following three or more risk factors for left ventricular dysfunction: Body mass index (BMI)≥30 kg/m2 History of systemic hypertension
•There is any of the following evidence to prove the history of major coronary artery disease:
•A coronary angiographic evidence of a history of myocardial infarction or percutaneous coronary intervention or coronary artery disease (at least one coronary artery stenosis \> 50%); B. Positive results of exercise provocation test and image evidence; C. previous coronary artery bypass surgery; D. stable angina pectoris; 2) Pulmonary function tests (PFTs) conducted within 180 days before or during the screening showed mild or above lung diseases. Subjects who meet any of the following criteria will be excluded: A. forced expiratory volume in the first second (FEV1)\<60% (expected value); or B total lung volume (TLC) \< 60% of the estimated value. 3) The evidence of thromboembolic disease is confirmed by lung ventilation/perfusion (V/Q) scanning or local standard diagnosis and treatment evaluation at the time of diagnosis or after diagnosis of PAH.
•4\) Severe chronic liver disease (i.e. Child-pugh grade C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (e.g., history of varicose bleeding, history of hepatic encephalopathy).
•5\) Confirm the active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV).
•6\) Subjects whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level is more than or equal to 3 times the normal upper limit value (ULN) or whose total bilirubin is more than or equal to 2 times ULN at the time of screening.
•7\) Chronic renal insufficiency at screening, which is defined as serum creatinine \> 2.5 mg/dL or requiring dialysis support.
•8\) Hemoglobin concentration \< 9 g/dL during screening. 9) diabetes. 10) cardiac function grade IV (NYHA classification) 11) The subject has been treated with IV or SC prostacyclin pathway drugs (for example, epoprostol, triprostinil or iloprost) at any time before baseline (allowed to be used in pulmonary vasodilation test).
•12\) The subject has pulmonary vein occlusion disease. 13) Diagnosed and/or treated with malignant tumor within 5 years before screening, but excluding localized non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or radical resection of cervical carcinoma in situ.
•14\) At the time of screening, there was a history of alcohol or drug abuse within 6 months.

Arms & Interventions

placebo in treatment pulmonary arterial hypertension

Intervention: placebo in treatment pulmonary aerterial hypertension

empagliflozin in treatment pulmonary arterial hypertension

Intervention: empagliflozin in treatment pulmonary aerterial hypertension

Outcomes

Primary Outcomes

6-minute walking distance

Time Frame: From enrollment to the end of treatment at 12 weeks

6-minute walking distance

Secondary Outcomes

Clinical deterioration event(From enrollment to the end of treatment at 12 weeks)
Cardiac function index(NT-proBNP, WHO functional classification)(From enrollment to the end of treatment at 12 weeks)
Hemodynamic index(From enrollment to the end of treatment at 12 weeks)
Health-related quality of life (HRQoL) index(From enrollment to the end of treatment at 12 weeks)
Cardiac magnetic resonance (CMR)(From enrollment to the end of treatment at 12 weeks)