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Pulmonary HypertensionPhase 3PADN-HF-PHNCT05824923

A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

A Phase 3 study testing Pulmonary arterial denervation and Guideline-directed medical therapy (GDMT) for heart failure in people with Pulmonary Hypertension and Heart Failure With Reduced Ejection Fraction, run by Pulnovo Medical (Wuxi) Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pulmonary arterial denervation and Guideline-directed medical therapy (GDMT) for heart failure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteChina
Study dates
14 Aug 2023to Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18, ≤75 years old;
  • Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
  • Clinically stable defined by
  • No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
  • Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg and resting heart rate (HR) ≥50 and <100 bpm (<110 bpm for atrial fibrillation) on the day of the procedure
  • New York Heart Association (NYHA) class II-IVa;
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  • 6MWD ≥ 100 m and < 450 m;
  • NT-proBNP > 125 pg/mL (BNP > 35 pg/mL);
  • Hemodynamic indicators (RHC) :
  • Mean pulmonary arterial pressure (mPAP) > 20 mmHg
  • Pulmonary capillary wedge pressure (PCWP) >15 mmHg
  • Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.

Who cannot join

  • Any of the following:
  • Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or
  • Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or
  • Untreated congenital heart disease; or
  • Have 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 or are anticipated to be implanted within 6 months; or
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  • 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)
  • Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
  • Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
  • Anticipated to undergo any surgery within 6 months;
  • The cardiac index (CI) of RHC < 1.5L/min/m²;
  • Severe renal insufficiency (eGFR <30mL/min/1.73m² by MDRD formula);
  • Severe liver insufficiency (Child-Pugh classification C);
  • Platelet count < 50 × 10^9/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;
  • Body mass index (BMI) >40 kg/m²;
  • Pregnant or lactating women, or plan to pregnant in one year;
  • Participated in other clinical trials within 3 months prior to signing the informed consent;
  • Any other circumstances that investigators deem inappropriate to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.

Read the detailed description

Chronic heart failure (CHF) patients who have received guideline-directed medical therapy (GDMT) based on the 2023 ESC Guidelines for HF and have reached clinical stable, and diagnosed with PH-LHD by right heart catheterization, will be randomized to the PADN group or control group in a 1:1 ratio to receive PADN combined with HF GDMT or HF GDMT, respectively. After the 12-month follow-up visit is completed, participants in the control group who still meet the inclusion and exclusion criteria can also choose to receive PADN.

Approximately 264 participants will be enrolled at up to 39 centers in China and followed for 3 years. The safety and efficacy of the PADN system, including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group.

Being tested
Pulmonary arterial denervation, Guideline-directed medical therapy (GDMT) for heart failure
Keywords
Pulmonary Artery Denervation, Pulmonary Hypertension Due to Left Heart Disease, Heart Failure, pulmonary hypertension, left heart failure
Medical subject headings
Hypertension, Pulmonary, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary arterial denervationProcedure or surgery

    Also called PADN

    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 ℃ for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.

    For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.

  • Guideline-directed medical therapy (GDMT) for heart failureDrug

    Also called GDMT medication for heart failure

    GDMT medication recommendation including:

    • Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI)
    • Beta-receptor blocker (BB)
    • Mineralocorticoid receptor antagonist (MRA)
    • Sodium-glucose co-transporter 2 (SGLT2) inhibitor
    • Diuretics

    The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion.

Study groups in NCT05824923
Study groupRoleWhat they receive
Pulmonary Artery Denervation (PADN)ExperimentalPatients in the PADN group will receive pulmonary artery denervation procedure.
Receives: Procedure: Pulmonary arterial denervation; Drug: Guideline-directed medical therapy (GDMT) for heart failure
Guideline-directed medical therapy (GDMT) for heart failureActive comparatorPatients in the control group will take their baseline anti-heart failure medications at the original doses according to 2023 ESC Guidelines for heart failure, without any changes except when medically required. The anti-heart failure drugs treatment is consistent in both arms.
Receives: Drug: Guideline-directed medical therapy (GDMT) for heart failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Worsening, defined as the occurrence of any of the followings:

    1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure
    2. Rehospitalization due to heart failure
    3. 6MWD decreased by > 10% or > 30m compared with baseline
    4. Referral for heart/heart-lung transplantation
    5. All-cause death

    Measured: immediately after the randomization to the last enrolled subject having at least 6 months follow-up

Secondary outcomes (17)

  1. Parameters measured by transthoracic echocardiography(TTE)

    Changes in left ventricular Tei index from baseline.

    Measured: 6 months, 1 year, 3 years

  2. Parameters measured by transthoracic echocardiography(TTE)

    Changes in left ventricular ejection fraction (LVEF) from baseline.

    Measured: 6 months, 1 year, 3 years

  3. Parameters measured by transthoracic echocardiography(TTE)

    Changes in left ventricular end-diastolic diameter (LVDd) from baseline.

    Measured: 6 months, 1 year, 3 years

  4. Parameters measured by transthoracic echocardiography(TTE)

    Changes in left ventricular end-systolic diameter (LVSd) from baseline.

    Measured: 6 months, 1 year, 3 years

  5. Parameters measured by transthoracic echocardiography(TTE)

    Changes in E/E' ratio from baseline.

    Measured: 6 months, 1 year, 3 years

  6. Parameters measured by transthoracic echocardiography(TTE)

    Changes in septum E' from baseline.

    Measured: 6 months, 1 year, 3 years

  7. Parameters measured by transthoracic echocardiography(TTE)

    Changes in lateral wall E' from baseline.

    Measured: 6 months, 1 year, 3 years

  8. Parameters measured by transthoracic echocardiography(TTE)

    Changes in left ventricular global longitudinal strain (LVGLS) from baseline.

    Measured: 6 months, 1 year, 3 years

  9. N-terminal pro-B-type natriuretic peptide (NT-proBNP)

    Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline

    Measured: 6 months

  10. 6 minute walk distance(6MWD) difference from baseline

    The 6MWD test was conducted according to the American Thoracic Society guidelines.

    Measured: 6 months, 1 year, 3 years

  11. Changes in the Kansas City Cardiomyopathy Questionnaire(KCCQ) overall summary score from baseline

    The KCCQ is a self-administered, 23-item questionnaire to provide a better description of quality of life in patients with heart failure. The overall summary score range from 0 to 100, higher score means higher quality of life.

    Measured: 1 month, 6 months, 1 year, 2 years, 3 years

  12. Intravenous medication due to worsening of heart failure

    Number of patients requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure

    Measured: 1 month, 6 months, 1 year, 2 years, 3 years

  13. Rehospitalization due to heart failure

    Number of patients with rehospitalization due to heart failure

    Measured: 1 month, 6 months, 1 year, 2 years, 3 years

  14. Heart/heart-lung transplantation

    Number of patients referred for heart/heart-lung transplantation

    Measured: 1 month, 6 months, 1 year, 2 years, 3 years

  15. All-cause death

    Number of death due to any cause

    Measured: 1 month, 6 months, 1 year, 2 years, 3 years

  16. Parameters measured by transthoracic echocardiography(TTE)

    Change in Left ventricular end-diastolic volume from baseline

    Measured: 6 months, 1 year, and 3 years

  17. Parameters measured by transthoracic echocardiography(TTE)

    Change in Left atrial volume index from baseline

    Measured: 6 months, 1 year, and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start14 Aug 2023
  3. Primary completion27 Aug 2025
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
At the 12-months visit, participants in the control group who still meet the inclusion and exclusion criteria can choose to receive PADN procedure.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05824923
Sponsor's protocol ID
Pulnovo-CO-2022-01
Acronym
PADN-HF-PH
Status last verified
Jul 2026
First submitted
10 Jan 2023
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang H, Wang Q, Liang M, Chen X, Zhuang W, Cheng B, Li Y, Shen J, Liu B, Zhang C, Zhang G, Liao X, Yang Z, He R, He Y, Cao Y, Wang Y, Chai D, Huang W, Peng X, Gu W, Stone GW, Han Y, Chen SL; PADN-HF-PH Investigators. Pulmonary Denervation for Heart Failure-Related Pulmonary Hypertension. N Engl J Med. 2026 Aug 30. doi: 10.1056/NEJMoa2609056. Online ahead of print.

    PubMed 42670986

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pulmonary arterial denervation and Guideline-directed medical therapy (GDMT) for heart failure in people with Pulmonary Hypertension and Heart Failure With Reduced Ejection Fraction, run by Pulnovo Medical (Wuxi) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Worsening, defined as the occurrence of any of the followings: (time frame: immediately after the randomization to the last enrolled subject having at least 6 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05824923, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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