A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

Korábbi kezelés

• 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
  • 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)
• Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
• Anticipated to undergo any surgery within 6 months;
• Participated in other clinical trials within 3 months prior to signing the informed consent;

Más betegség

• Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
• The cardiac index (CI) of RHC < 1.5L/min/m²;
• Severe liver insufficiency (Child-Pugh classification C);
• Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
• Active infection requiring oral or intravenous antibiotics;

Laborértékek

• Severe renal insufficiency (eGFR <30mL/min/1.73m² by MDRD formula);
• Platelet count < 50 × 10\^9/L;

Egyéb

• Life expectancy <1 year;
• Body mass index (BMI) >40 kg/m²;
• Pregnant or lactating women, or plan to pregnant in one year;
• Any other circumstances that investigators deem inappropriate to participate in this trial.

• 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);
• Hemodynamic indicators (RHC) :
  • Mean pulmonary arterial pressure (mPAP) > 20 mmHg
  • Pulmonary capillary wedge pressure (PCWP) >15 mmHg
• Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.