Pulmonary Arterial HypertensionPhase 1NCT06554301
A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
A Phase 1 study testing empagliflozin in treatment pulmonary aerterial hypertension in people with Pulmonary Arterial Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- empagliflozin in treatment pulmonary aerterial hypertension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- PAH is accompanied by:
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- 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:
- 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).
- There are symptoms of WHO/NYHA FC Grade II or III.
- Stable PAH targeted background oral therapy. Subjects received endothelin receptor antagonist (ERA) and/or phosphodiesterase inhibitor type 5 (PDE5-I) or soluble guanylate cyclase (sGC) agonist. Stability was defined as no change in dose or regimen within 30 days before baseline and during the duration of the study.
- 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 throughout the study.
- If there is the possibility of pregnancy, both male and female subjects should agree to use a highly effective contraceptive method during the whole study period (from informed consent to the end of follow-up).
Who cannot join
- 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.
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- 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.
- 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 interventional 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 subjects meet all other selection criteria and comply with all research process requirements.
- 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 collaboration, so that the subject cannot participate in the study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Tingting Guo, M.D, +86 18610094559, 18610094559@163.com
Lu Hua, M.D
About this study
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.
Read more
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
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- empagliflozin in treatment pulmonary aerterial hypertension, placebo in treatment pulmonary aerterial hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozin in treatment pulmonary aerterial hypertensionDrug
On the basis of background treatment, the experimental group was given 10 mg of empagliflozin tablets orally once a day for 12 weeks.
placebo in treatment pulmonary aerterial hypertensionDrug
On the basis of background treatment, the control group was given 10 mg of placebo tablets orally once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| placebo in treatment pulmonary arterial hypertension | Placebo comparator | Not described Receives: Drug: placebo in treatment pulmonary aerterial hypertension |
| empagliflozin in treatment pulmonary arterial hypertension | Experimental | Not described Receives: Drug: empagliflozin in treatment pulmonary aerterial hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking distance
6-minute walking distance
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Clinical deterioration event
Clinical deterioration event
Measured: From enrollment to the end of treatment at 12 weeks
Cardiac function index(NT-proBNP, WHO functional classification)
Cardiac function index(NT-proBNP, WHO functional classification)
Measured: From enrollment to the end of treatment at 12 weeks
Hemodynamic index
Hemodynamic index
Measured: From enrollment to the end of treatment at 12 weeks
Health-related quality of life (HRQoL) index
Health-related quality of life (HRQoL) index
Measured: From enrollment to the end of treatment at 12 weeks
Cardiac magnetic resonance (CMR)
Cardiac magnetic resonance (CMR)
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- The Second Hospital of Shandong University, The First People's Hospital of Changzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554301
- Sponsor's protocol ID
- NCRCSZ-2023-015
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06554301
- Acronym / sponsor ID
- NCRCSZ-2023-015
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- The Second Hospital of Shandong University, The First People's Hospital of Changzhou
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo in treatment pulmonary arterial hypertension | Placebo comparator | Drug: placebo in treatment pulmonary aerterial hypertension |
| empagliflozin in treatment pulmonary arterial hypertension | Experimental | Drug: empagliflozin in treatment pulmonary aerterial hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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:
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empagliflozin in treatment pulmonary aerterial hypertensionOn the basis of background treatment, the experimental group was given 10 mg of empagliflozin tablets orally once a day for 12 weeks. | Drug | empagliflozin in treatment pulmonary arterial hypertension |
| placebo in treatment pulmonary aerterial hypertensionOn the basis of background treatment, the control group was given 10 mg of placebo tablets orally once a day for 12 weeks. | Drug | placebo in treatment pulmonary arterial hypertension |
Primary outcome
6-minute walking distance
Time frame: From enrollment to the end of treatment at 12 weeks
6-minute walking distance
5 secondary outcomes
Clinical deterioration event
Time frame: From enrollment to the end of treatment at 12 weeks
Cardiac function index(NT-proBNP, WHO functional classification)
Time frame: From enrollment to the end of treatment at 12 weeks
Hemodynamic index
Time frame: From enrollment to the end of treatment at 12 weeks
Health-related quality of life (HRQoL) index
Time frame: From enrollment to the end of treatment at 12 weeks
Cardiac magnetic resonance (CMR)
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing empagliflozin in treatment pulmonary aerterial hypertension in people with Pulmonary Arterial Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingting Guo, M.D (+86 18610094559, 18610094559@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking distance (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.