Heart Failure With Reduced Ejection Fraction (HFrEF)Phase 2/3PAST-HFrEFNCT07820410
Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
A Phase 2/3 study testing D-shant Atrial Shunt and Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- D-shant Atrial Shunt and Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2024to 31 Dec 2027
- Phase
- Phase 2/3
- 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
- 1. Age ≥ 18 years 2. Diagnosed with HFrEF and receiving Guideline-Directed Medical Therapy (GDMT) for at least 1 month 3. Echocardiographic LVEF between 20% and 40% (20 ≤ LVEF ≤ 40%) 4. Presence of HF-related symptoms and signs, NYHA Class III 5. At least one HF-related hospitalization in the past year or NT-proBNP ≥ 600 pg/mL (sinus rhythm) / ≥ 1000 pg/mL (atrial fibrillation) 6. Invasive hemodynamics: mLAP or mPCWP ≥ 15 mmHg, or left-to-right mean pressure gradient ≥ 5 mmHg 7. Fully understand the study design and follow-up schedule, agrees to participate, and voluntarily signs the Informed Consent Form
Who cannot join
- 1. End-stage heart failure on the heart transplant waiting list (including meeting LVAD indications) 2. Three consecutive non-invasive systolic blood pressure readings < 90 mmHg 3. Primary structural valvular disease currently indicating surgery or interventional therapy, or severe coronary artery disease requiring revascularization 4. ECG QRS duration ≥ 130 ms with high risk of sudden cardiac death without therapeutic intervention (including meeting CRT/CRT-D indications) 5. Significant right ventricular (RV) dysfunction or severe pulmonary hypertension. Defined by clinical evidence of hepatic congestion, moderate-to-severe edema, or abdominal distension accompanied by poor appetite; significant right atrial or RV enlargement/dysfunction; moderate-to-severe tricuspid regurgitation; mean right atrial pressure > 10 mmHg; systolic pulmonary artery pressure > 60 mmHg; or pulmonary vascular resistance > 3 Wood Units 6. Myocardial infarction or cardiac intervention within the past 1 month 7. Stroke within the past 1 month (excluding lacunar infarction) 8. Decompensated liver cirrhosis (Child-Pugh Class B or worse), or severe chronic pulmonary disease requiring oxygen therapy 9. Anatomical abnormalities precluding procedure completion or making the patient unsuitable for procedure 10. Atrial thrombosis 11. Contraindication to antithrombotic therapy 12. Life expectancy < 1 year 13. Uncontrolled active infection 14. Pregnant, lactating, or women of childbearing potential planning pregnancy in the near future 15. Currently participating in another drug or medical device clinical trial 16. Investigator deems the patient unsuitable for this trial
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
Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Sanshuai Chang, M.D., +8618501369869, 18501369869@163.com
About this study
Official title: A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
Read the detailed description
This is a prospective, randomized, open-label, parallel-controlled, superiority, multicenter clinical study. A total of 208 subjects will be randomized 1:1 after meeting all inclusion/exclusion criteria.
Treatment Group: atrial shunt implantation post-right heart catheterization. Control Group: Right heart catheterization only. Both groups will receive standardized Guideline-Directed Medical Therapy (GDMT) post-procedure. Assessments and follow-ups will be conducted at pre-procedure baseline, day of procedure, 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure.
A Clinical Event Committee (CEC), composed of third-party cardiovascular experts, will independently review and adjudicate primary endpoints in a blinded manner (surgical information concealed).
- Being tested
- D-shant Atrial Shunt, Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
- Keywords
- Heart Failure with Reduced Ejection Fraction, Atrial shunt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-shant Atrial ShuntDevice
The D-Shant atrial shunt device is a novel device therapy for heart failure, classified as a non-active implantable cardiovascular device. It is manufactured using a braided Nitinol technique, thermally set via assembly molds to form a waist with a fixed-orifice support and a hollow double-disc structure. Braided wires reinforce waist support and maintain a circular orifice shape. Once implanted, it forms a stable interatrial shunt. The device is delivered via the femoral vein to the interatrial septum, where the shunt orifice facilitates blood flow diversion and pressure decompression. Various models with different waist and disc diameters are available to accommodate varying degrees and etiologies of heart failure.
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fractionDrug
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
| Study group | Role | What they receive |
|---|---|---|
| Device group (Interventional group) | Experimental | Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease Receives: Device: D-shant Atrial Shunt; Drug: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction |
| no Device group (Control Group) | Active comparator | Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only Receives: Drug: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months. Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or <24 hours if subject dies in the emergency room). - Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay <24 hours. - Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (24)
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Change in exercise capacity post-procedure: 6-Minute Walk Test
Measured: From enrollment to the end of treatment at 12 months
New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome）
Change in New York Heart Association (NYHA) Functional Classification
Measured: From enrollment to the end of treatment at 12 months
Change in NT-proBNP levels
Change in NT-proBNP levels
Measured: From enrollment to the end of treatment at 12 months
Left atrial diameter
Echocardiographic Left atrial diameter
Measured: From enrollment to the end of treatment at 12 months
Device Success Rates (Treatment Group)
Device Success is defined as successful implantation of the shunt with normal morphology and position, visible left-to-right shunt on echocardiography, and an immediate decrease in mean Left Atrial Pressure (mLAP) or mean Pulmonary Capillary Wedge Pressure (mPCWP) compared to pre-implantation.
Measured: From enrollment to the end of treatment at 12 months
Changes in 12-lead Electrocardiogram (ECG)
Presence of arrhythmias
Measured: From enrollment to the end of treatment at 12 months
Shunt Orifice Patency/Occlusion Status (Treatment Group)
Shunt Orifice Patency/Occlusion Status (Treatment Group)
Measured: From enrollment to the end of treatment at 12 months
All-cause mortality rate
All-cause mortality rate
Measured: From enrollment to the end of treatment at 12 months
Number of HF-related rehospitalizations post-procedure
Number of HF-related rehospitalizations post-procedure
Measured: From enrollment to the end of treatment at 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Measured: From enrollment to the end of treatment at 12 months
Right atrial diameter
Echocardiographic right atrial diameter
Measured: From enrollment to the end of treatment at 12 months
Left ventricular diameter
Echocardiographic left ventricular diameter
Measured: From enrollment to the end of treatment at 12 months
Right ventricular diameter
Echocardiographic reft atrial diameter
Measured: From enrollment to the end of treatment at 12 months
Left Ventricular Ejection Fraction
Echocardiographic Left Ventricular Ejection Fraction
Measured: From enrollment to the end of treatment at 12 months
Tricuspid Annular Plane Systolic Excursion
Echocardiographic Tricuspid Annular Plane Systolic Excursion
Measured: From enrollment to the end of treatment at 12 months
Right Ventricular Fractional Area
Echocardiographic Right Ventricular Fractional Area
Measured: From enrollment to the end of treatment at 12 months
Aortic regurgitation
Echocardiographic aortic regurgitation
Measured: From enrollment to the end of treatment at 12 months
Mitral regurgitation
Echocardiographic mitral regurgitation
Measured: From enrollment to the end of treatment at 12 months
Tricuspid regurgitation
Echocardiographic tricuspid regurgitation
Measured: From enrollment to the end of treatment at 12 months
Shunt orifice diameter
Echocardiographic Shunt orifice diameter
Measured: From enrollment to the end of treatment at 12 months
Shunt flow velocity
Echocardiographic shunt flow velocity
Measured: From enrollment to the end of treatment at 12 months
Trans-shunt pressure gradient
Echocardiographic trans-shunt pressure gradient
Measured: From enrollment to the end of treatment at 12 months
Shunt flow direction
Echocardiographic shunt flow direction
Measured: From enrollment to the end of treatment at 12 months
Procedural Success Rates (Treatment Group)
Procedural Success is defined as achieving Device Success with the patient surviving to hospital discharge.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start25 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangyuan Song, Beijing Anzhen Hospital
- Investigators
- Guangyuan Song, M.D., Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820410
- Sponsor's protocol ID
- BeijingAnzhen20260716
- Acronym
- PAST-HFrEF
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT07820410
- Acronym / sponsor ID
- PAST-HFrEF / BeijingAnzhen20260716
- Keywords
- Heart Failure with Reduced Ejection Fraction, Atrial shunt
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2026 (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.
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
Detailed description
This is a prospective, randomized, open-label, parallel-controlled, superiority, multicenter clinical study. A total of 208 subjects will be randomized 1:1 after meeting all inclusion/exclusion criteria.
Treatment Group: atrial shunt implantation post-right heart catheterization. Control Group: Right heart catheterization only. Both groups will receive standardized Guideline-Directed Medical Therapy (GDMT) post-procedure. Assessments and follow-ups will be conducted at pre-procedure baseline, day of procedure, 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure.
A Clinical Event Committee (CEC), composed of third-party cardiovascular experts, will independently review and adjudicate primary endpoints in a blinded manner (surgical information concealed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device group (Interventional group) | Experimental | Device: D-shant Atrial Shunt, Drug: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fractionPatients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease |
| no Device group (Control Group) | Active comparator | Drug: Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fractionPatients will receive maximally tolerated guideline-directed medical therapy for heart failure only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years 2. Diagnosed with HFrEF and receiving Guideline-Directed Medical Therapy (GDMT) for at least 1 month 3. Echocardiographic LVEF between 20% and 40% (20 ≤ LVEF ≤ 40%) 4. Presence of HF-related symptoms and signs, NYHA Class III 5. At least one HF-related hospitalization in the past year or NT-proBNP ≥ 600 pg/mL (sinus rhythm) / ≥ 1000 pg/mL (atrial fibrillation) 6. Invasive hemodynamics: mLAP or mPCWP ≥ 15 mmHg, or left-to-right mean pressure gradient ≥ 5 mmHg 7. Fully understand the study design and follow-up schedule, agrees to participate, and voluntarily signs the Informed Consent Form
Key exclusion criteria (1 listed)
- 1. End-stage heart failure on the heart transplant waiting list (including meeting LVAD indications) 2. Three consecutive non-invasive systolic blood pressure readings < 90 mmHg 3. Primary structural valvular disease currently indicating surgery or interventional therapy, or severe coronary artery disease requiring revascularization 4. ECG QRS duration ≥ 130 ms with high risk of sudden cardiac death without therapeutic intervention (including meeting CRT/CRT-D indications) 5. Significant right ventricular (RV) dysfunction or severe pulmonary hypertension. Defined by clinical evidence of hepatic congestion, moderate-to-severe edema, or abdominal distension accompanied by poor appetite; significant right atrial or RV enlargement/dysfunction; moderate-to-severe tricuspid regurgitation; mean right atrial pressure > 10 mmHg; systolic pulmonary artery pressure > 60 mmHg; or pulmonary vascular resistance > 3 Wood Units 6. Myocardial infarction or cardiac intervention within the past 1 month 7. Stroke within the past 1 month (excluding lacunar infarction) 8. Decompensated liver cirrhosis (Child-Pugh Class B or worse), or severe chronic pulmonary disease requiring oxygen therapy 9. Anatomical abnormalities precluding procedure completion or making the patient unsuitable for procedure 10. Atrial thrombosis 11. Contraindication to antithrombotic therapy 12. Life expectancy < 1 year 13. Uncontrolled active infection 14. Pregnant, lactating, or women of childbearing potential planning pregnancy in the near future 15. Currently participating in another drug or medical device clinical trial 16. Investigator deems the patient unsuitable for this trial
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 |
|---|---|---|
| D-shant Atrial ShuntThe D-Shant atrial shunt device is a novel device therapy for heart failure, classified as a non-active implantable cardiovascular device. It is manufactured using a braided Nitinol technique, thermally set via assembly molds to form a waist with a fixed-orifice support and a hollow double-disc structure. Braided wires reinforce waist support and maintain a circular orifice shape. Once implanted, it forms a stable interatrial shunt. The device is delivered via the femoral vein to the interatrial septum, where the shunt orifice facilitates blood flow diversion and pressure decompression. Various models with different waist and disc diameters are available to accommodate varying degrees and etiologies of heart failure. | Device | Device group (Interventional group) |
| Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fractionGuideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction | Drug | Device group (Interventional group), no Device group (Control Group) |
Primary outcome
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
Time frame: From enrollment to the end of treatment at 12 months
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months. Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or <24 hours if subject dies in the emergency room). - Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay <24 hours. - Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
24 secondary outcomes
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
Time frame: From enrollment to the end of treatment at 12 months
New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome）
Time frame: From enrollment to the end of treatment at 12 months
Change in NT-proBNP levels
Time frame: From enrollment to the end of treatment at 12 months
Left atrial diameter
Time frame: From enrollment to the end of treatment at 12 months
Device Success Rates (Treatment Group)
Time frame: From enrollment to the end of treatment at 12 months
Changes in 12-lead Electrocardiogram (ECG)
Time frame: From enrollment to the end of treatment at 12 months
Shunt Orifice Patency/Occlusion Status (Treatment Group)
Time frame: From enrollment to the end of treatment at 12 months
All-cause mortality rate
Time frame: From enrollment to the end of treatment at 12 months
Number of HF-related rehospitalizations post-procedure
Time frame: From enrollment to the end of treatment at 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）
Time frame: From enrollment to the end of treatment at 12 months
Right atrial diameter
Time frame: From enrollment to the end of treatment at 12 months
Left ventricular diameter
Time frame: From enrollment to the end of treatment at 12 months
Right ventricular diameter
Time frame: From enrollment to the end of treatment at 12 months
Left Ventricular Ejection Fraction
Time frame: From enrollment to the end of treatment at 12 months
Tricuspid Annular Plane Systolic Excursion
Time frame: From enrollment to the end of treatment at 12 months
Right Ventricular Fractional Area
Time frame: From enrollment to the end of treatment at 12 months
Aortic regurgitation
Time frame: From enrollment to the end of treatment at 12 months
Mitral regurgitation
Time frame: From enrollment to the end of treatment at 12 months
Tricuspid regurgitation
Time frame: From enrollment to the end of treatment at 12 months
Shunt orifice diameter
Time frame: From enrollment to the end of treatment at 12 months
Shunt flow velocity
Time frame: From enrollment to the end of treatment at 12 months
Trans-shunt pressure gradient
Time frame: From enrollment to the end of treatment at 12 months
Shunt flow direction
Time frame: From enrollment to the end of treatment at 12 months
Procedural Success Rates (Treatment Group)
Time frame: From enrollment to the end of treatment at 12 months
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 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
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.
Guangyuan Song, M.D. principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing D-shant Atrial Shunt and Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Beijing Anzhen Hospital 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 1 inclusion and 1 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 15 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sanshuai Chang, M.D. (+8618501369869, 18501369869@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months (time frame: From enrollment to the end of treatment at 12 months). 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 15 Sep 2026.