Clareo Health | 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）
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）
3. 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;
4. Clinically stable HF for at least 1 month, defined as:
1. No need of intravenous diuretics, inotropes or vasodilators, and
2. Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg, and
3. Resting heart rate (HR) ≥ 50 bpm and \<100 bpm (\>110 bpm in presence of atrial fibrillation) on the day of the procedure.
5. NYHA class II-IVa;
6. 6MWD ≥ 100 m and ≤ 450 m;
7. NT-proBNP \>125pg/mL (or BNP \> 35pg/mL);
8. Understand and be willing to sign informed consent and be strictly willing to follow the protocol.
You may not be if
1. Any of the following:
1. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
2. Pericardial disease; or
3. Infiltrative or inflammatory myocardial disease; or
4. Valvular heart disease with stenosis or with severe regurgitation; or
5. Active endocarditis; or
6. Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
7. Congenital heart disease; or
8. 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
9. 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
10. Anticipated to undergo ablation of atrial fibrillation within 6 months; or
11. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or
12. Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD)
2. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
3. Anticipated to undergo any surgery within the next 6 months;
4. Cardiac index (CI) measured by RHC \< 1.5L/min/m2;
5. Severe renal insufficiency (eGFR \< 30mL/min/1.73m2 by MDRD formula);
6. Severe liver insufficiency (Child-Pugh classification B-C);
7. Platelet count \< 50 × 109/L;
8. Life expectancy \< 1 year;
9. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
10. Active infection requiring oral or intravenous antibiotics;
11. Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;
12. Body mass index (BMI) \> 40 kg/m²;
13. Pregnant or lactating women, or planning to be pregnant within one year;
14. Participation in other clinical trials within 3 months prior to signing the informed consent;
15. Any other circumstances that investigators deemed inappropriate to participate in this trial.
