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 2026-12-30
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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical worsening
Timeframe: From randomization to 12 months
Trial details
NCT IDNCT07331220
SponsorNanjing First Hospital, Nanjing Medical University
. 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.
. 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.