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

Study Purpose

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 (CpcPH) associated with chronic heart failure(CHF). 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18, ≤75 years; 2. CpcPH must be confirmed by RHC, defined as: 1. Mean pulmonary arterial pressure (mPAP) > 20mmHg; 2. Pulmonary capillary wedge pressure (PCWP) > 15mmHg; 3. Pulmonary vascular resistance (PVR) > 2WU; 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.

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 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05996562
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pulnovo Medical (Wuxi) Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Heart Failure

Arms & Interventions

Arms

Experimental: Pulmonary Artery Denervation (PADN)

Interventions

Procedure: - Pulmonary Artery Denervation

Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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