To assess the impact of PADN combined with guideline-directed medical therapy (GDMT) versus a sham procedure with GDMT on clinical outcomes in heart failure (HF) patients with preserved left ventricular ejection fraction (LVEF\>40%). Outcomes include cardiovascular death, HF-related rehospitalization, requirement for heart transplantation or need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Age <50 years: BNP >100 pg/mL or NT-proBNP >450 pg/mL
Age 50-75 years: BNP >150 pg/mL or NT-proBNP >900 pg/mL
Age >75 years: BNP >200 pg/mL or NT-proBNP >1800 pg/mL
BNP >150 pg/mL or NT-proBNP >300 pg/mL
Hospitalization for HF within 7 days prior to screening.
Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.
History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.
Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.
Parallel
PADN
Procedure/SurgeryAdvancing the pulmonary artery denervation catheter with a diameter to vessel of 1.1\~1.2:1 through the long sheath to the left pulmonary artery ostium. Connecting the catheter to the RF generator. Rotate the catheter under imaging so the premounted electrodes tightly contact the target ablation positions. Recommended temperature-controlled mode, set temperature to 50°C, ablation time to 150 seconds (with effective ablation time of 120 seconds, defined as the tissue temperature reaches 45°C-55°C. Ablation is performed at a total of 3 sites with 120 seconds for each.
Sham procedure
Procedure/SurgeryThe ablation catheter under imaging guidance will be advanced to the target ablation points, but DO NOT connect the ablation catheter to the RF generator; DO NOT deliver RF energy. The operator issues commands to "start" and "stop" RF ablation, simulating the sound of the PADN RF generator for at least 2 minutes (using a pre-recorded MP4).
GDMT
DrugGDMT regimen including sodium-glucose co-transporter 2 inhibitor (SGLT2i) + spironolactone. SGLT2i can be dapagliflozin or empagliflozin. * Dapagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently \<25 mL/min/1.73 m². * Empagliflozin: Target maintenance dose 10 mg/day. Contraindicated if eGFR persistently \<20 mL/min/1.73 m². * Spironolactone: Starting dose 10-20 mg/day, maximum dose 40 mg/day. Suspend if serum potassium is \>5.5 mmol/L; restart at half dose after correction. Permanently discontinue if serum potassium is \>6.0 mmol/L. Suspend and evaluate if eGFR persistently declines \>30% or \<30 mL/min/1.73 m². Other medications are left at the physician's discretion.
Clinical worsening
A composite of clinical worsening at 12 months, including cardiovascular death, HF-related rehospitalization, requirement for heart transplantation, need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Clinical worsening
A composite of clinical worsening at 24 months, including cardiovascular death, HF-related rehospitalization, requirement for heart transplantation, need of valvular treatment or LVAD or pacemaker implantation, and worsening in outpatients (defined as requirement for intravenous therapy or diuretic intensification, including increasing the types or dose of diuretics).
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
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.
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Change in NT-proBNP levels at 1 month, 6 months, and 12 months.
6-minute walk distance (6MWD)
The 6-minute walk test in patients with chronic heart failure is clinically graded as follows: A distance of less than 150 meters indicates severe heart failure with poor prognosis; 150 to 300 meters corresponds to moderate heart failure; 300 to 450 meters reflects mild heart failure; and a distance greater than 450 meters suggests near-normal cardiac function and a relatively better clinical status.
Loop diuretic dose
Weekly loop diuretic dose (furosemide equivalent) change
SGLT2i dose
Weekly SGLT2i dose (dapagliflozin or empagliflozin) change
NYHA functional class
Change in New York Heart Association (NYHA) functional class at 12 months.
Mortality
All-cause mortality
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Nanjing First Hospital, Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator
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