Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction (NCT07331220) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction
China310 participantsStarted 2025-12-30
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients WITHOUT atrial fibrillation:
✓. 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
✓. Patients WITH atrial fibrillation:
✓. BNP \>150 pg/mL or NT-proBNP \>300 pg/mL
✓. Hospitalization for decompensated HF within the past 12 months
✓. Received intravenous loop diuretic or ultrafiltration for HF within the past 12 months
Exclusion criteria
✕. 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.
What they're measuring
1
Clinical worsening
Timeframe: From randomization to 12 months
Trial details
NCT IDNCT07331220
SponsorNanjing First Hospital, Nanjing Medical University
✕. 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.
✕. 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.
✕. Cardiac resynchronization therapy (CRT) within 90 days prior to screening.
✕. 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.