Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:47 AM
Study NCT ID:
NCT07331220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction
Sponsor:
Nanjing First Hospital, Nanjing Medical University
Organization:
Study Overview
Official Title:
Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PADN-HFpEF
Brief 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).
Detailed Description:
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%.
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%.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: