An interventional study of PADN and Sham procedure in Heart Failure With Preserved Ejection Fraction, sponsored by Nanjing First Hospital, Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment
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).
A randomized, multicenter, blinded, sham-controlled trial in
Subjects with chronic HFpEF (LVEF >40%) meeting inclusion criteria and no exclusion criterion will be enrolled from 25 + centers in China within 24 months. Patients will be randomized 1:1 to:
GDMT regimen: Sodium-glucose co-transporter 2 inhibitor (SGLT2i) + Spironolactone. SGLT2i can be dapagliflozin or empagliflozin.
Other medications are left at the physician's discretion. The proportion of patients with persistent atrial fibrillation is not to exceed 35%.
Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
2. Both male and female subjects age between 18 \~ 85 years old. 3. Dyspnea on exertion (NYHA functional class II-IV) not explained by non-cardiac or ischemic etiology.
4. LVEF >40% on imaging within 24 months prior to enrollment, with no clinical changes suggesting worsening systolic function.
5. Elevated NT-proBNP or BNP levels meeting the following thresholds stratified by age and atrial fibrillation (AF) status:
Patients WITHOUT atrial fibrillation:
Patients WITH atrial fibrillation:
BNP >150 pg/mL or NT-proBNP >300 pg/mL
6. Stable HF GDMT (no change in either types or dose) for ≥14 days prior to enrollment, including SGLT2i and spironolactone. Other medication, including angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitor (ARNI, sacubitril/valsartan), beta-blockers, or calcium channel blockers (CCBs), were left at physician's discretion.
7. Dose changes of ACEIs, ARBs, sacubitril/valsartan, beta-blockers, or CCBs did not exceed 100% of baseline dose (i.e., no doubling or halving).
8. Continuous diuretic use for ≥14 days prior to screening, with stable dose in the last 7 days.
9. Meet at least one of the following:
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Exclusion Criteria:
Pulmonary artery denervation combined with guideline-directed medical therapy.
Procedure: PADN · Drug: GDMT
Sham procedure combined with guideline-directed medical therapy
Procedure: Sham procedure · Drug: GDMT
Advancing 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.
Also known as: Pulmonary artery denervation, Right heart catheterization
The 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 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.
Also known as: Guideline-directed medical therapy
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).
Time frame: From randomization to 12 months
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).
Time frame: From baseline to 24 months
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.
Time frame: From baseline to 12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Change in NT-proBNP levels at 1 month, 6 months, and 12 months.
Time frame: From baseline to 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.
Time frame: From baseline to 1 month, 6 months, and 12 months
KCCQ-CSS increase ≥6 points
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.
Time frame: From baseline to 12 months
NT-proBNP reduction ≥20%
Proportion of patients with NT-proBNP reduction ≥20% at 6, 12 months
Time frame: From baseline to 6 months and 12 months
KCCQ-CSS increase ≥6 points and NT-proBNP reduction ≥20%
KCCQ-CSS and NT-proBNP will be combined to report heart failure-related health status.
Time frame: From baseline to 6 months and 12 months
Echocardiographic parameters (chamber size, systolic and diastolic function)
Echocardiographic parameters, such as left ventricular ejection fraction (LVEF), ventricular volumes, and diastolic function indices (e.g., E/e' ratio), serve as key quantitative endpoints to evaluate cardiac remodeling and therapeutic response.
Time frame: From baseline to 6 months
Rate of worsening in outpatients
requiring intravenous injection of medicines, or needing diuretic intensification (including increase in types or doses of diuretics).
Time frame: Within 12 months
Rate of heart or lung transplantation
For patients with progressive heart failure
Time frame: within 12 months
Rate of left ventricular assist device implantation
Incidence of left ventricular assist device (LVAD) implantation, defined as the proportion of patients undergoing LVAD surgery during the study follow-up period.
Time frame: Within 12 months
Requirement of pacemaker / physiologic pacing / CRT / ICD/valvular treatment
Indications for pacemaker: Symptomatic sinus node dysfunction, High-grade AV block (Mobitz II or complete heart block), and Post-TAVI or post-MI advanced conduction disease when persistent. Indications for CRT: LVEF ≤35%, Sinus rhythm, LBBB morphology, QRS ≥150 ms, NYHA II-III or ambulatory IV, or others (determined by EP team). Indications for valvular treatment: Aortic Stenosis (AS), Aortic Regurgitation (AR) with Symptoms or Asymptomatic but LVEF ≤55% and/or progressive LV dilation, Primary (degenerative) Mitral Regurgitation (MR) Symptoms or LV dysfunction developing (LVEF ≤60%, Tricuspid Regurgitation (TR), Mitral Stenosis (MS), or others.
Time frame: Within 12 months
All events within 24 months
All patients will be followed-up until 24 months
Time frame: Within 24 months
Loop diuretic dose
Weekly loop diuretic dose (furosemide equivalent) change
Time frame: From baseline to 12 months
SGLT2i dose
Weekly SGLT2i dose (dapagliflozin or empagliflozin) change
Time frame: From baseline to 12 months
NYHA functional class
Change in New York Heart Association (NYHA) functional class at 12 months.
Time frame: From baseline to 12 months
Mortality
All-cause mortality
Time frame: From baseline to 12 months
Cardiovascular mortality
Time frame: From baseline to 12 months
Rate of non-fatal myocardial infarction
Time frame: From baseline to 12 months
Rate of stroke
Time frame: From baseline to 12 months
Rate of acute kidney injury
Acute kidney injury (serum creatinine doubling based on modified RIFLE criteria).
Time frame: From baseline to 12 months
Adverse events (AEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) and Serious Adverse Events (SAEs), including access site complications (e.g., bleeding, hematoma).
Time frame: From baseline to 12 months
Plan to share: Yes — DATA sharing could be accepted upon other researchers reached out to the PI of this trial, with approval.
Supporting information: Analytic code
No publications or documents are linked to this record.
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Nanjing First Hospital, Nanjing Medical University