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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2028-12-30

Brief Summary

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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).

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Detailed Description

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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:

* Experimental Group: PADN + GDMT
* Control Group: Sham procedure + GDMT

GDMT regimen: 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. The proportion of patients with persistent atrial fibrillation is not to exceed 35%.

Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be assigned to undergo either PADN plus GDMT or sham procedure plus GDMT

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Staff from the core laboratories

Study Groups

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PADN plus GDMT

Pulmonary artery denervation combined with guideline-directed medical therapy.

Group Type EXPERIMENTAL

PADN

Intervention Type PROCEDURE

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.

GDMT

Intervention Type DRUG

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.

Sham procedure plus GDMT

Sham procedure combined with guideline-directed medical therapy

Group Type PLACEBO_COMPARATOR

Sham procedure

Intervention Type 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).

GDMT

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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Pulmonary artery denervation Right heart catheterization Guideline-directed medical therapy

Eligibility Criteria

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Inclusion Criteria

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:

1. Patients WITHOUT atrial fibrillation:

1. Age \<50 years: BNP \>100 pg/mL or NT-proBNP \>450 pg/mL
2. Age 50-75 years: BNP \>150 pg/mL or NT-proBNP \>900 pg/mL
3. Age \>75 years: BNP \>200 pg/mL or NT-proBNP \>1800 pg/mL
2. Patients WITH atrial fibrillation:

1. 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:



1. Hospitalization for decompensated HF within the past 12 months
2. Received intravenous loop diuretic or ultrafiltration for HF within the past 12 months
3. Documented resting pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) \>15 mmHg, or exercise PCWP ≥25 mmHg, or exercise LVEDP ≥20 mmHg on right heart catheterization within the past 12 months
4. Echocardiographic evidence within the past 24 months of left atrial enlargement (LA anterior-posterior diameter male \>40 mm, female \>38 mm; LA area ≥20 cm², LA volume index ≥29 ml/m²) or left ventricular hypertrophy (interventricular septal thickness or LV posterior wall thickness ≥12 mm).

Exclusion Criteria

1. Hospitalization for HF within 7 days prior to screening.
2. Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.
3. History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.
4. Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.
5. Hospitalization within 30 days prior to screening for: acute ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina, percutaneous coronary intervention (PCI), or cardiac surgery.
6. Cardiac resynchronization therapy (CRT) within 90 days prior to screening.
7. Planned revascularization (PCI or CABG), major cardiac surgery (including coronary artery bypass grafting, valve replacement, ventricular assist device implantation, heart transplantation, other surgery requiring thoracotomy), transcatheter aortic valve replacement (TAVR), or CRT implantation within 90 days after screening.
8. History of femoral or jugular vein surgery.
9. Life expectancy \<1 year at screening.
10. Estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73 m² at screening (calculated using the modified MDRD formula).
11. BNP \<150 pg/ml and NT-proBNP \<300 pg/ml at screening.
12. Serum potassium \>5.5 mmol/L at screening.
13. Physical examination showing volume depletion at screening or randomization.
14. Mean supine systolic blood pressure \<100 mmHg at screening or randomization.
15. Uncontrolled hypertension, defined as mean supine systolic blood pressure ≥160 mmHg (average of three measurements) at screening.
16. Documented stable-state LVEF \<40% within the past 24 months.
17. Current active malignancy (excluding non-melanoma skin cancer).
18. HF due to specific cardiomyopathies, including: restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular stenosis, hypertrophic obstructive cardiomyopathy (HOCM).
19. Chronic obstructive pulmonary disease (COPD) judged as the primary cause of dyspnea.
20. Myocardial ischemia judged as the primary cause of dyspnea.
21. Isolated right heart failure due to pulmonary disease.
22. Complex congenital heart disease.
23. History of allergic reaction to guideline-directed HF medications.
24. Pregnant/lactating women. Women of childbearing potential (WOCBP) defined as post-menarche and not permanently sterilized (hysterectomy/bilateral tubal ligation) or postmenopausal (natural amenorrhea ≥12 months without other medical cause). Sexually active WOCBP must agree to use medically accepted contraception during the study, including: \|surgical sterilization, progestin contraceptives (oral/implant), barrier methods (condom/diaphragm) with spermicide, intrauterine device (IUD). Urine pregnancy test required at each visit; negative result required for continued participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No