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).
Age <50 years: BNP >100 pg/mL or NT-proBNP >450 pg/mL
Age 50-75 years: BNP >150 pg/mL or NT-proBNP >900 pg/mL
Age >75 years: BNP >200 pg/mL or NT-proBNP >1800 pg/mL
BNP >150 pg/mL or NT-proBNP >300 pg/mL
Hospitalization for HF within 7 days prior to screening.
Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.
History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.
Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.
Nanjing First Hospital, Nanjing Medical University
Lead sponsor
Nanjing Medical University
Collaborator