A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of … (NCT05824923) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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;
✓. NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL);
Exclusion criteria
✕. Any of the following:
✕. 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
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
✕. 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