Heart Failure With Reduced Ejection FractionPCI-GULFNCT07349979
PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF
A study testing Percutaneous coronary intervention and Guideline-directed medical therapy in people with Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months… 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, Coronary Artery Disease, Stable GDMT
- What is being tested?
- Percutaneous coronary intervention and Guideline-directed medical therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,154 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2026to 30 Jan 2028
- Phase
- Interventional
- 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
- Age ≥18 years at screening.
- Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.
- Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg/mL.
- Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated DS of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist.
- On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.
- The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures.
Who cannot join
- Class III or IV angina requiring revascularization.
- Any unplanned hospitalization within 30 days.
- Any PCI within 12 months.
- Any prior CABG.
- Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)
- Non-cardiac life expectancy <1 year at screening (e.g., malignancy, advanced liver disease).
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- Coronary anatomy requiring surgical revascularization by local heart team determination.
- Coronary anatomy unsuitable for PCI.
- HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).
- Severe stenosis or regurgitation of any heart valve.
- Contraindication to dual antiplatelet therapy or iodinated contrast.
- Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential.
- Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.
- Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.
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
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
About this study
Official title: Percutaneous Coronary Intervention With Guideline-Directed Medical Therapy Versus Guideline-Directed Medical Therapy Alone for Patients With Ischemic Cardiomyopathy and Reduced Left Ventricular Ejection Fraction: A Randomized, Controlled, Open-Label, Multicenter PCI-GULF Trial
To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular [CV] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device [LVAD] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.
Read the detailed description
A prospective, randomized, controlled, open-label, multicenter trial with blinded endpoint adjudication (PROBE design)
A total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT，will be assigned at 1:1 ratio to:
Experimental Group: PCI with contemporary DES + GDMT. Control Group: GDMT alone.
Angiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated diameter stenosis (DS) of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions are considered amenable to PCI with DES by an interventional cardiologist.
Randomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center.
Complete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days. However, it is recommended that chronic total occlusions are only treated if they supply viable myocardium (preserved regional wall motion or viability by cardiac MR or PET).
All PCIs in any lesion with reference vessel diameter ≥2.5 mm MUST be guided by intravascular imaging (IVUS or OCT). The use of mechanical circulatory system (including IABP, Impella, or ECMO) is left at operator's discretion. Drug-coated balloon (DCB) alone is not recommended, but the combination of DES with DCB (e.g. for diffuse distal disease or side branch treatment of a bifurcation lesion) is left to operator's discretion.
Both arms receive optimized GDMT according to current guidelines. Given the nature of the intervention (PCI vs. no PCI), treating physicians and patients cannot be blinded. To minimize bias, a PROBE design is employed with a blinded independent Clinical Events Committee (CEC), blinded core laboratories, and blinded statisticians. The catheterization laboratory team is unblinded but not involved in follow-up decisions or endpoint assessments.
Clinic/telephone follow-up is conducted at 30 days, 3, 6, 9, 12 months and then yearly until the time that the last patient enrolled has reached 12-month follow-up. In addition, at this time, a final "sweep" visit (phone call) will be made to all patients who have not had a follow-up completed within 30 days.
All subjects in both groups receive evidence based GDMT and dual antiplatelet therapy (DAPT) per guidelines throughout the study.
- Being tested
- Percutaneous coronary intervention, Guideline-directed medical therapy
- Keywords
- HFrEF, PCI, GDMT, MACE
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Also called PCI
PCI will be performed according to standard techniques. Use of a contemporary, FDA/CE-approved drug-eluting stent is mandatory.
Guideline-directed medical therapyDrug
Also called GDMT
GDMT optimization follows a structured titration algorithm:
Week 0: introducing angiotensin-converting enzyme inhibitor (ACEi)/ angiotensin II receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitors (ARNI) and beta-blockers.
Week 1: adding mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i).
Adjust every 2-4 weeks to reach target or tolerable dose unless symptomatic hypotension (systolic blood pressure [SBP] < 90 mmHg) or estimated glomerular filtration rate (eGFR) drop > 30 % or serum potassium >5.2 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| PCI with contemporary DES + GDMT | Active comparator | A total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT，will be assigned at 1:1 ratio to two arms.
Angiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated diameter stenosis (DS) of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions are considered amenable to PCI with DES by an interventional cardiologist.
Randomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center.
Complete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days. Receives: Procedure: Percutaneous coronary intervention; Drug: Guideline-directed medical therapy |
| GDMT only | Active comparator | The control group will receive GDMT; this is approved treatments for preventing HF that could be utilised as a comparator. All patients will be treated according to local guidelines on standard of care treatment for patients with HFrEF and post PCI, focusing on treatment of HF symptoms (e.g. diuretics) and comorbidities (including treatment for high blood pressure, ischaemic heart disease). Receives: Drug: Guideline-directed medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
MACE is a composite of cardiovascular [CV] death, myocardial infarction, HF-related rehospitalization, heart transplantation, requirement for durable LVAD, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications (out-patient worsening HF) through a median of at least 24-month follow-up, measured at the time the last enrolled patient reaches 12-month follow-up.
Measured: From randomization to the time when the last enrolled patient reaches 12-month follow-up.
Secondary outcomes (13)
Rate of cardiovascular death plus myocardial infarction and revascularization
This endpoint measures the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction, or unplanned ischemia-driven revascularization.
Measured: The last patient reaches the 12-month follow-up
Rate of cardiovascular death
A death that is primarily caused by a cardiovascular event or condition. This includes deaths resulting from acute myocardial infarction, stroke, heart failure, arrhythmias, and other cardiovascular diseases.
Measured: The last patient reaches the 12-month follow-up
Rate of myocardial infarction
The diagnosis of an myocardial infarction should be made according to standard clinical practice but is expected to align with the criteria from Fourth Universal Definition of MI, i.e. detection of a rise and/or fall of cardiac biomarkers such as troponin and at least one of the following: typical clinical symptoms, ischaemic ECG findings, imaging evidence of myocardial injury, or detection of an intracoronary thrombus by angiography or autopsy.
Measured: The last patient reaches the 12-month follow-up period
Rate of any unplanned revascularization
Unplanned revascularization includes all coronary revascularization procedures (PCI/CABG) performed during the study.
Measured: The last patient reaches the 12-month follow-up period
Rate of heart failure-related rehospitalization
Heart failure readmission is defined as a hospitalization or extended emergency visit due to acute worsening of heart failure, requiring all of the following: a primary HF diagnosis, symptom deterioration, objective evidence of worsening, and intensified HF-specific therapy.
Measured: The last patient reaches the 12-month follow-up period
Incidence of device implantation procedure
Device implants include valve therapy, pacemakers or left ventricular assistive devices.
Measured: The last patient reaches the 12-month follow-up period
Heart transplantation
Rate of heart transplantation refers to the frequency at which patients in a study undergo surgical replacement of their native heart with a donor heart.
Measured: The last patient reaches the 12-month follow-up period
Rate of worsening heart failure
worsening HF including intravenous medications in outpatients.
Measured: The last patient reaches the 12-month follow-up period
All-cause mortality
All-cause mortality refers to the death of a participant from any cause during the study period.
Measured: The last patient reaches the 12-month follow-up period
Change in LVEF
Change in LVEF refers to the absolute or relative difference in Left Ventricular Ejection Fraction measured from randomization to the 12-month follow-up period.
Measured: The last patient reaches the 12-month follow-up period
Change from baseline in NT-proBNP concentration at 12 months
Change in NT-proBNP refers to the absolute or relative difference in NT-proBNP measured from randomization to the 12-month follow-up period.
Measured: The last patient reaches the 12-month follow-up period
Total number of (first and recurrent) MACE
heart failure and cardiovascular death will be combined to report heart failure-related health status.
Measured: The last patient reaches the 12-month follow-up period
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) is a percentage-based health index ranging from 0 to 100, where higher scores indicate better heart failure-related health status.
Measured: The last patient reaches the 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (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 FractionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PCI with DES plus GDMT versus GDMT alone
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,154 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349979
- Sponsor's protocol ID
- KY20251223-09
- Other IDs
- BE2019615
- Acronym
- PCI-GULF
- Status last verified
- May 2026
- First submitted
- 8 Jan 2026
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Intervention With Guideline-Directed Medical Therapy Versus Guideline-Directed Medical Therapy Alone for Patients With Ischemic Cardiomyopathy and Reduced Left Ventricular Ejection Fraction: A Randomized, Controlled, Open-Label, Multicenter PCI-GULF Trial
- ClinicalTrials.gov ID
- NCT07349979
- Acronym / sponsor ID
- PCI-GULF / KY20251223-09
- Keywords
- HFrEF, PCI, GDMT, MACE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,154 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 20 Jan 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 whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular [CV] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device [LVAD] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.
Detailed description
A prospective, randomized, controlled, open-label, multicenter trial with blinded endpoint adjudication (PROBE design)
A total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT，will be assigned at 1:1 ratio to:
Experimental Group: PCI with contemporary DES + GDMT. Control Group: GDMT alone.
Angiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated diameter stenosis (DS) of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions are considered amenable to PCI with DES by an interventional cardiologist.
Randomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center.
Complete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days. However, it is recommended that chronic total occlusions are only treated if they supply viable myocardium (preserved regional wall motion or viability by cardiac MR or PET).
All PCIs in any lesion with reference vessel diameter ≥2.5 mm MUST be guided by intravascular imaging (IVUS or OCT). The use of mechanical circulatory system (including IABP, Impella, or ECMO) is left at operator's discretion. Drug-coated balloon (DCB) alone is not recommended, but the combination of DES with DCB (e.g. for diffuse distal disease or side branch treatment of a bifurcation lesion) is left to operator's discretion.
Both arms receive optimized GDMT according to current guidelines. Given the nature of the intervention (PCI vs. no PCI), treating physicians and patients cannot be blinded. To minimize bias, a PROBE design is employed with a blinded independent Clinical Events Committee (CEC), blinded core laboratories, and blinded statisticians. The catheterization laboratory team is unblinded but not involved in follow-up decisions or endpoint assessments.
Clinic/telephone follow-up is conducted at 30 days, 3, 6, 9, 12 months and then yearly until the time that the last patient enrolled has reached 12-month follow-up. In addition, at this time, a final "sweep" visit (phone call) will be made to all patients who have not had a follow-up completed within 30 days.
All subjects in both groups receive evidence based GDMT and dual antiplatelet therapy (DAPT) per guidelines throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- PCI with DES plus GDMT versus GDMT alone
| Arm | Type | Receives |
|---|---|---|
| PCI with contemporary DES + GDMT | Active comparator | Procedure: Percutaneous coronary intervention, Drug: Guideline-directed medical therapyA total of 1154 patients with LVEF ≤40%, angiographically proven coronary artery disease (CAD) amenable to PCI, and symptomatic heart failure (NYHA Class II-IV) on stable GDMT，will be assigned at 1:1 ratio to two arms. Angiographically proven CAD is defined as 1) a visually estimated diameter stenosis (DS) of ≥90%, or 2) a chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated diameter stenosis (DS) of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions are considered amenable to PCI with DES by an interventional cardiologist. Randomization will be stratified by the presence of planned CTO PCI, planned left main PCI and center. Complete revascularization of all angiographically significant lesions is encouraged, to be performed either during the index procedure or within a staged procedure within 30 days. |
| GDMT only | Active comparator | Drug: Guideline-directed medical therapyThe control group will receive GDMT; this is approved treatments for preventing HF that could be utilised as a comparator. All patients will be treated according to local guidelines on standard of care treatment for patients with HFrEF and post PCI, focusing on treatment of HF symptoms (e.g. diuretics) and comorbidities (including treatment for high blood pressure, ischaemic heart disease). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years at screening.
- Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.
- Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg/mL.
- Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated DS of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist.
- On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.
Key exclusion criteria (14 listed)
- Class III or IV angina requiring revascularization.
- Any unplanned hospitalization within 30 days.
- Any PCI within 12 months.
- Any prior CABG.
- Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)
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 |
|---|---|---|
| Percutaneous coronary interventionAlso: PCIPCI will be performed according to standard techniques. Use of a contemporary, FDA/CE-approved drug-eluting stent is mandatory. | Procedure or surgery | PCI with contemporary DES + GDMT |
| Guideline-directed medical therapyAlso: GDMTGDMT optimization follows a structured titration algorithm: Week 0: introducing angiotensin-converting enzyme inhibitor (ACEi)/ angiotensin II receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitors (ARNI) and beta-blockers. Week 1: adding mineralocorticoid receptor antagonist (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i). Adjust every 2-4 weeks to reach target or tolerable dose unless symptomatic hypotension (systolic blood pressure [SBP] < 90 mmHg) or estimated glomerular filtration rate (eGFR) drop > 30 % or serum potassium >5.2 mmol/L. | Drug | GDMT only, PCI with contemporary DES + GDMT |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: From randomization to the time when the last enrolled patient reaches 12-month follow-up.
MACE is a composite of cardiovascular [CV] death, myocardial infarction, HF-related rehospitalization, heart transplantation, requirement for durable LVAD, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications (out-patient worsening HF) through a median of at least 24-month follow-up, measured at the time the last enrolled patient reaches 12-month follow-up.
13 secondary outcomes
Rate of cardiovascular death plus myocardial infarction and revascularization
Time frame: The last patient reaches the 12-month follow-up
Rate of cardiovascular death
Time frame: The last patient reaches the 12-month follow-up
Rate of myocardial infarction
Time frame: The last patient reaches the 12-month follow-up period
Rate of any unplanned revascularization
Time frame: The last patient reaches the 12-month follow-up period
Rate of heart failure-related rehospitalization
Time frame: The last patient reaches the 12-month follow-up period
Incidence of device implantation procedure
Time frame: The last patient reaches the 12-month follow-up period
Heart transplantation
Time frame: The last patient reaches the 12-month follow-up period
Rate of worsening heart failure
Time frame: The last patient reaches the 12-month follow-up period
All-cause mortality
Time frame: The last patient reaches the 12-month follow-up period
Change in LVEF
Time frame: The last patient reaches the 12-month follow-up period
Change from baseline in NT-proBNP concentration at 12 months
Time frame: The last patient reaches the 12-month follow-up period
Total number of (first and recurrent) MACE
Time frame: The last patient reaches the 12-month follow-up period
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: The last patient reaches the 12-month follow-up period
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 28 May 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.
Shao-Liang Chen, MD principal investigator
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention and Guideline-directed medical therapy in people with Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 May 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.
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 Shao-Liang Chen, MD (+86-25-52271351, chmengx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: From randomization to the time when the last enrolled patient reaches 12-month follow-up.). 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 28 May 2026.