Heart FailureNCT06323512
Pulmonary Arteyr Denervation for HF Without PH
An observational study of Heart Failure, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure > 20 mmHg and pulmonary artery wedge pressure >15 mmHg at rest, as determined by right heart catheterization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pulmonary artery denervation (PADN)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 May 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure
Who may be able to join
- aged 18 years or greater, had a documented history of chronic (≥6 months) ischaemic or non-ischaemic cardiomyopathy; ACC/AHA stage C heart failure criteria, NYHA class III or ambulatory class IV symptoms; on GDMT for heart failure at least three months; PAWP exceeding 15 mm Hg, mean PAP less than or equal to 20 mm Hg, and PVR less than or equal to 2 Woods Unit
Who cannot join
- Patients lacked patent femoral venous or inferior vena cava/right jugular vein access; had experienced a stroke or thromboembolic event within the preceding 12 months, had patent foramen ovale or atrial septal defect, or presented with severe (grade 4) mitral regurgitation; had coagulation disorders or contraindications for oral anticoagulation; had harboring pulmonary artery, right atrial or right ventricular thrombus; had undergone pacemaker implantation within 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Artery Denervation for Treatment of Patients With Heart Failure Without Pulmonary Hypertension: a Safety and Proof-of-principle Cohort Study
Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure > 20 mmHg and pulmonary artery wedge pressure >15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR > 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF).
Read the detailed description
We conducted a safety and proof-of-principle cohort study at a single centre in China. Eligible patients, aged 18 years or greater, had a documented history of chronic (≥6 months) ischaemic or non-ischaemic cardiomyopathy. They also met the American College of Cardiology/American Heart Association (ACC/AHA) stage C heart failure criteria, with New York Heart Association (NYHA) class III or ambulatory class IV symptoms. Additionally, participants were required to have been receiving guideline-directed medical therapy for at least three months, as tolerated per ACC/AHA guidelines.
Further inclusion criteria encompassed a pulmonary artery wedge pressure exceeding 15 mm Hg, a mean pulmonary arterial pressure less than or equal to 20 mm Hg, and pulmonary vascular resistance (PVR) less than or equal to 2 Woods Unit. Patients were ineligible if they lacked patent femoral venous or inferior vena cava/right jugular vein access, or exhibited a plasma N-terminal prohormone B-type natriuretic peptide (NT-proBNP) level below 300 pg/ml, had experienced a stroke or thromboembolic event within the preceding 12 months, had patent foramen ovale or atrial septal defect, or presented with severe (grade 4) mitral regurgitation. Patients with coagulation disorders or contraindications for oral anticoagulation, as well as those harboring pulmonary artery, right atrial, or right ventricular thrombus, were also excluded.
- Conditions
- Heart Failure
- Being tested
- Pulmonary artery denervation (PADN)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary artery denervation (PADN)Device
Combining invasive angiography with pulmonary artery CTA is frequently employed to determine the final size of the PADN catheter, aiming for an expected ratio of distal ring/vessel diameter between 1.1 and 1.2. The PADN system comprises a radiofrequency generator, connecting tubing and control handle, and the PADN catheter. The main interface of the radiofrequency generator offers multiple language options and displays parameters such as temperature, impedance, energy, and ablation time. The generator features three control modes: temperature control, power control, and a combination of both.
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular dp/dt (maximal and minimal)
Measured: before and immediately after PADN procedures
Left ventricular end-systolic pressure (maximal and minimal)
Measured: Before and immediately after PADN procedures
Secondary outcomes (3)
Pulmonary arterial wedge pressure
PAWP
Measured: Before, after-PADN and at 3 months
Tricuspid annuls peak systolic excursion
TAPSE
Measured: Before, after-PADN and at 3 months
NT-proBNP
N-terminal-pro brain natriuretic peptide
Measured: Before, after-PADN and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Aug 2024
- Primary completion1 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Hongjuan C Peng, MBBS, Study director, Nanjing First Hospital, Nanjing Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323512
- Sponsor's protocol ID
- Nanjing
- Status last verified
- Jun 2025
- First submitted
- 14 Mar 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang X, Zhang H, Zhang J, Gu Y, Xie D, Wang Z, Chen SL. Pulmonary artery denervation improves left ventricular diastolic function in patients with isolated post-capillary pulmonary hypertension secondary to heart failure with preserved ejection fraction: a safety and proof-of-principle cohort study. AsiaIntervention. 2026 Mar 19;12(1):41-49. doi: 10.4244/AIJ-D-25-00061. eCollection 2026 Mar.
PubMed 41835997
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Denervation for Treatment of Patients With Heart Failure Without Pulmonary Hypertension: a Safety and Proof-of-principle Cohort Study
- ClinicalTrials.gov ID
- NCT06323512
- Acronym / sponsor ID
- Nanjing
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure > 20 mmHg and pulmonary artery wedge pressure >15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR > 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF).
Detailed description
We conducted a safety and proof-of-principle cohort study at a single centre in China. Eligible patients, aged 18 years or greater, had a documented history of chronic (≥6 months) ischaemic or non-ischaemic cardiomyopathy. They also met the American College of Cardiology/American Heart Association (ACC/AHA) stage C heart failure criteria, with New York Heart Association (NYHA) class III or ambulatory class IV symptoms. Additionally, participants were required to have been receiving guideline-directed medical therapy for at least three months, as tolerated per ACC/AHA guidelines.
Further inclusion criteria encompassed a pulmonary artery wedge pressure exceeding 15 mm Hg, a mean pulmonary arterial pressure less than or equal to 20 mm Hg, and pulmonary vascular resistance (PVR) less than or equal to 2 Woods Unit. Patients were ineligible if they lacked patent femoral venous or inferior vena cava/right jugular vein access, or exhibited a plasma N-terminal prohormone B-type natriuretic peptide (NT-proBNP) level below 300 pg/ml, had experienced a stroke or thromboembolic event within the preceding 12 months, had patent foramen ovale or atrial septal defect, or presented with severe (grade 4) mitral regurgitation. Patients with coagulation disorders or contraindications for oral anticoagulation, as well as those harboring pulmonary artery, right atrial, or right ventricular thrombus, were also excluded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure
Key inclusion criteria (1 listed)
- aged 18 years or greater, had a documented history of chronic (≥6 months) ischaemic or non-ischaemic cardiomyopathy; ACC/AHA stage C heart failure criteria, NYHA class III or ambulatory class IV symptoms; on GDMT for heart failure at least three months; PAWP exceeding 15 mm Hg, mean PAP less than or equal to 20 mm Hg, and PVR less than or equal to 2 Woods Unit
Key exclusion criteria (1 listed)
- Patients lacked patent femoral venous or inferior vena cava/right jugular vein access; had experienced a stroke or thromboembolic event within the preceding 12 months, had patent foramen ovale or atrial septal defect, or presented with severe (grade 4) mitral regurgitation; had coagulation disorders or contraindications for oral anticoagulation; had harboring pulmonary artery, right atrial or right ventricular thrombus; had undergone pacemaker implantation within 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary artery denervation (PADN)Combining invasive angiography with pulmonary artery CTA is frequently employed to determine the final size of the PADN catheter, aiming for an expected ratio of distal ring/vessel diameter between 1.1 and 1.2. The PADN system comprises a radiofrequency generator, connecting tubing and control handle, and the PADN catheter. The main interface of the radiofrequency generator offers multiple language options and displays parameters such as temperature, impedance, energy, and ablation time. The generator features three control modes: temperature control, power control, and a combination of both. | Device | – |
Primary outcome
Left ventricular dp/dt (maximal and minimal)
Time frame: before and immediately after PADN procedures
Left ventricular end-systolic pressure (maximal and minimal)
Time frame: Before and immediately after PADN procedures
3 secondary outcomes
Pulmonary arterial wedge pressure
Time frame: Before, after-PADN and at 3 months
Tricuspid annuls peak systolic excursion
Time frame: Before, after-PADN and at 3 months
NT-proBNP
Time frame: Before, after-PADN and at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 41835997Jiang X, Zhang H, Zhang J, Gu Y, Xie D, Wang Z, Chen SL. Pulmonary artery denervation improves left ventricular diastolic function in patients with isolated post-capillary pulmonary hypertension secondary to heart failure with preserved ejection fraction: a safety and proof-of-principle cohort study. AsiaIntervention. 2026 Mar 19;12(1):41-49. doi: 10.4244/AIJ-D-25-00061. eCollection 2026 Mar.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongjuan C Peng, MBBS study director
Nanjing First Hospital, Nanjing Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Nanjing First Hospital, Nanjing Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jun 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left ventricular dp/dt (maximal and minimal) (time frame: before and immediately after PADN procedures). The study lists 2 primary outcomes in all. 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 NCT06323512, 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 26 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.