Clinical trial NCT05996562: 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）
Official title: Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension
Heart Failure
Keywords: Pulmonary Artery Denervation
PADN
Pulmonary Hypertension
Heart Failure
Lead sponsor: Pulnovo Medical (Wuxi) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: 6-minute walk distance (6MWD) difference
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital de Santa Marta
Study officials:
References: