Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07331220
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%.
Study:
NCT07331220
Study Brief:
Protocol Section:
NCT07331220