Status:
RECRUITING
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）
Lead Sponsor:
Pulnovo Medical (Wuxi) Co., Ltd.
Conditions:
Pulmonary Hypertension
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 Fai...
Eligibility Criteria
Inclusion
- 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 \< 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.
Exclusion
- 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;
- Cardiac index (CI) measured by RHC \< 1.5L/min/m2;
- Severe renal insufficiency (eGFR \< 30mL/min/1.73m2 by MDRD formula);
- Severe liver insufficiency (Child-Pugh classification B-C);
- Platelet count \< 50 × 109/L;
- Life expectancy \< 1 year;
- Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
- Active infection requiring oral or intravenous antibiotics;
- 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;
- Participation in other clinical trials within 3 months prior to signing the informed consent;
- Any other circumstances that investigators deemed inappropriate to participate in this trial.
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05996562
Start Date
June 28 2024
End Date
December 1 2026
Last Update
January 6 2026
Active Locations (1)
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1
Hospital de Santa Marta
Lisbon, Portugal