CClinicalTrials.gg
CompletedNCT05996562Updated Jan 16, 2026

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)

An interventional study of Pulmonary Artery Denervation in Pulmonary Hypertension and Heart Failure, sponsored by Pulnovo Medical (Wuxi) Co., Ltd.. Completed at 1 site in Portugal. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Pulnovo Medical (Wuxi) Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Hypertension
  • Heart Failure

Keywords

  • Pulmonary Artery Denervation
  • PADN
  • Pulmonary Hypertension
  • Heart Failure
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 30 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Pulnovo Medical (Wuxi) Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18, ≤85 years;
  2. PH must be confirmed by RHC, defined as:

    1. Mean pulmonary arterial pressure (mPAP) >20mmHg, and;
    2. Pulmonary capillary wedge pressure (PCWP) >15mmHg, and;
    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

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 \< 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Pulmonary Artery Denervation (PADN)

    Procedure: Pulmonary Artery Denervation

Interventions

  • ProcedurePulmonary 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.

06

What researchers measure

Primary outcomes

  1. 6-minute walk distance (6MWD) difference

    The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.

    Time frame: 6 months

07

Study locations

1 site
  • Hospital de Santa Marta
    Lisbon, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05996562
Lead sponsor
Pulnovo Medical (Wuxi) Co., Ltd.
Responsible party
Sponsor
First posted
Aug 18, 2023
Start date
Jun 28, 2024
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026
Last update
Jan 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion