A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of … (NCT05824923) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
China264 participantsStarted 2023-08-14
Plain-language summary
It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.
Who can participate
Age range
18 Years – 75 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
. Age ≥18, ≤75 years old;
. Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
. Clinically stable defined by
. No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
. Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg and resting heart rate (HR) ≥50 and \<100 bpm (\<110 bpm for atrial fibrillation) on the day of the procedure
. New York Heart Association (NYHA) class II-IVa;
. 6MWD ≥ 100 m and \< 450 m;
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.
1This trial focuses on pulmonary artery denervation for pulmonary hypertension linked to left heart failure — my doctor mentioned my diagnosis involves both of these, so is this the type of procedure and condition combination that would have even been relevant for someone in my situation?
2Since the trial is in Phase 3 and is actively running but no longer enrolling new patients, does that mean results might be published soon, and should we wait to see those findings before deciding on any treatment path?
3The main thing this trial is measuring is 'clinical worsening' — things like hospitalizations or disease progression — so can you explain what that means for my specific case and whether the current standard treatments we're considering are already aimed at preventing those same outcomes?
4This trial covers several types of heart failure — reduced, preserved, and mid-range ejection fraction — and my diagnosis falls into one of these categories, so how does my specific type of heart failure affect whether a procedure like pulmonary artery denervation would even be appropriate to discuss for me?
5Given that this is a surgical or interventional procedure targeting the pulmonary artery, what are the risks I should understand compared to continuing with medication-based management, and are there any results from earlier phases of this kind of research we could look at together?
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, defined as the occurrence of any of the followings:
Timeframe: immediately after the randomization to the last enrolled subject having at least 6 months follow-up
. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or
. Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or
. Untreated congenital heart disease; or
. Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or
. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or
. Anticipated to undergo ablation of atrial fibrillation within 6 months; or
. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or