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）

Conditions: Pulmonary Hypertension; Heart Failure

Summary: the goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (padn) in combined post- and pre- capillary pulmonary hypertension associated with chronic heart failure. participants who have received guideline-directed medical therapy (gdmt) according to 2022 aha/acc guidelines for heart failure (hf) and have been clinically stable for at least 1 month, will be treated with padn and followed for 1 year.


Eligibility criteria:
inclusion criteria: 1. age ≥18, ≤85 years; 2. ph must be confirmed by rhc, defined as: 1. mean pulmonary arterial pressure (mpap) \&gt; 20mmhg, and; 2. pulmonary capillary wedge pressure (pcwp) \&gt;15mmhg. 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 \&lt; 160 mmhg, and 3. resting heart rate (hr) ≥ 50 bpm and \&lt;100 bpm (\&lt;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 \&gt;125pg/ml (or bnp \&gt; 35pg/ml); 8. understand and be willing to sign informed consent and be strictly willing to follow the protocol. exclusion criteria: 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 \&lt; 1.5l/min/m2; 5. severe renal insufficiency (egfr \&lt; 30ml/min/1.73m2 by mdrd formula); 6. severe liver insufficiency (child-pugh classification b-c); 7. platelet count \&lt; 50 × 109/l; 8. life expectancy \&lt; 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) \&gt; 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.

Keywords: pulmonary artery denervation padn pulmonary hypertension heart failure