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Tests treatment safety and results for Pulmonary Arterial Hypertension
Official title A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT06554301
What this study is testing
What is empagliflozin in treatment pulmonary aerterial hypertension?
empagliflozin in treatment pulmonary aerterial hypertension is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pulmonary arterial hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years old.
- Sign the informed consent form.
- people who are willing and able to comply with the requirements of prescribed visits, treatment plans, laboratory examinations and other research...
- PAH with symptoms was initially diagnosed and belonged to one of the following subgroups: A. Idiopathic pulmonary hypertension (IPAH); B. hereditary...
- 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...
You likely can't join if
- 1) people shall not have the following three or more risk factors for left ventricular dysfunction: Body mass index (BMI)≥30 kg/m2 History of...
- 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...
- 4) Severe chronic liver disease (i.e. Child-pugh grade C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (e.g...
- 5) Confirm the active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV).
- 6) people whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level is more than or equal to 3 times the normal upper limit...
See the full eligibility criteria
- At least 18 years old.
- Sign the informed consent form.
- people 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...
- 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...
- There are symptoms of WHO/NYHA FC Grade II or III.
- Stable PAH targeted background oral therapy. people received endothelin receptor antagonist (ERA) and/or phosphodiesterase inhibitor type 5 (PDE5-I) or soluble guanylate cyclase (sGC) agonist. Stability was defined as...
- 6-minute walking distance (6 MWD) ≥ 150m.
- If the subject is taking concomitant drugs that can affect PAH (for example, calcium channel blockers, digoxin or L- arginine supplements), the dose must be kept stable for at least 30 days before the baseline visit and...
- If there is the possibility of pregnancy, both male and female people should agree to use a highly effective contraceptive method during the whole study period (from informed consent to the end of follow-up).
- 1) people 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...
- 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) people 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...
- 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...
- 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...
- 14) At the time of screening, there was a history of alcohol or drug abuse within 6 months.
- 15) Start the exercise-based cardiopulmonary rehabilitation program within 90 days of the screening period and/or during the study period.
- 16) Participated in other treatment clinical studies within 30 days before screening. It is allowed to participate in registered or observational studies at the same time, as long as the people meet all other selection...
- 17) Any reason (for example, any past or intermittent diseases) that the respondent thinks may increase the risk of participating in the study or may affect the study analysis and damage the study participation or...
- 18) Those who are known to be allergic to Engelgin or any auxiliary materials. 19) According to the researcher\'s judgment, life expectancy is less than 12 months.
- 20) Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.