drugset / Trial / NCT07331220

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

NCT07331220

RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2026-12-30
Primary completion
2028-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Background Dapagliflozin Small molecule 10 mg
Background Empagliflozin Small molecule 10 mg
Background Spironolactone Small molecule 10 mg
Background Spironolactone Small molecule 20 mg
Background Spironolactone Small molecule 40 mg