A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Disease (PADN-HF-PH)
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Artery Denervation, Pulmonary Hypertension Due to Left Heart Disease, Heart Failure, pulmonary hypertension, left heart failure
Eligibility Criteria
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 2022 AHA/ACC 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 ACC/AHA stage of heart failure B-C; New York Heart Association (NYHA) class II-IVa; World Health Organization (WHO) functional class II-IV; 6MWD ≥ 100 m and < 450 m; NT-proBNP > 600 pg/mL (BNP > 150 pg/mL), or NT-proBNP > 400 pg/mL (BNP >100pg/mL) and has been hospitalized for heart failure in the past 1 year; Hemodynamic indicators (RHC) : Mean pulmonary arterial pressure (mPAP) > 25mmHg Pulmonary capillary wedge pressure (PCWP) >15mmHg Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol. Exclusion Criteria: Any of the following: Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM); pericardial disease; infiltrative or inflammatory myocardial disease; valvular heart disease with moderate or severe stenosis of any of the 4 valves, or severe regurgitation of any of the 4 valves, or active endocarditis; or Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or Complex 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 Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD) Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5; Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization; Anticipated to undergo any surgery within 6 months; The cardiac index (CI) of RHC < 1.5L/min/m²; Severe renal insufficiency (eGFR <30mL/min/1.73m² by MDRD formula); Severe liver insufficiency (Child-Pugh classification B-C); Platelet count < 50 × 10^9/L; Life expectancy <1 year; Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants; Active infection requiring oral or intravenous antibiotics; Cannot tolerate any GDMT medicine; Body mass index (BMI) >40 kg/m²; Pregnant or lactating women, or plan to pregnant in one year; Participated in other clinical trials within 3 months prior to signing the informed consent; Any other circumstances that investigators deem inappropriate to participate in this trial.
Sites / Locations
- General Hospital of Northern Theater Command
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pulmonary Artery Denervation (PADN)
Guideline-directed medical therapy (GDMT) for heart failure
Patients in the PADN group will receive pulmonary artery denervation procedure.
Patients in the control group will take their baseline anti-heart failure medications at the original doses according to 2022 AHA/ACC Guidelines for heart failure, without any changes except when medically required. The anti-heart failure drugs treatment is consistent in both arms.