Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction

Summary

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).

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

PROCEDURE

PADN

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.

PROCEDURE

Sham procedure

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).

DRUG

GDMT

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.

Sponsors & Collaborators

• Nanjing Medical University

  collaborator OTHER

• Nanjing First Hospital, Nanjing Medical University

  lead OTHER

Principal Investigators

• Shao-Liang Chen, MD · Nanjing First Hospital, Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-30

Primary Completion

2028-12-30

Completion

2028-12-30

Countries

• China

Study Locations