Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure（PADN-CpcPH-PILOT）

Korábbi kezelés

• Any of the following:
  • Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
  • Pericardial disease; or
  • Infiltrative or inflammatory myocardial disease; or
  • Valvular heart disease with stenosis or with severe regurgitation; or
  • Active endocarditis; or
  • Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
  • Congenital heart disease; or
  • Having 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 less than 6 months 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 the next 6 months;
• Participation in other clinical trials within 3 months prior to signing the informed consent;

Más betegség

• Cardiac index (CI) measured by RHC < 1.5L/min/m2;
• Severe liver insufficiency (Child-Pugh classification B-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 × 109/L;

Egyéb

• Life expectancy < 1 year;
• Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;
• Body mass index (BMI) > 40 kg/m²;
• Pregnant or lactating women, or planning to be pregnant within one year;
• Any other circumstances that investigators deemed inappropriate to participate in this trial.

• Age ≥18, ≤85 years;
• PH must be confirmed by RHC, defined as:
  • Mean pulmonary arterial pressure (mPAP) >20mmHg, and;
  • Pulmonary capillary wedge pressure (PCWP) >15mmHg, and；
  • Pulmonary vascular resistance (PVR) > 2WU.
• Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;
• Clinically stable HF for at least 1 month, defined as:
  • No need of intravenous diuretics, inotropes or vasodilators, and
  • Systolic blood pressure (SBP) ≥ 100 and \&lt; 160 mmHg, and
  • Resting heart rate (HR) ≥ 50 bpm and <100 bpm (>110 bpm in presence of atrial fibrillation) on the day of the procedure.
• NYHA class II-IVa;
• 6MWD ≥ 100 m and ≤ 450 m;
• NT-proBNP >125pg/mL (or BNP > 35pg/mL);
• Understand and be willing to sign informed consent and be strictly willing to follow the protocol.