Pulmonary HypertensionNCT05996562
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）
A study testing Pulmonary Artery Denervation in people with Pulmonary Hypertension and Heart Failure, run by Pulnovo Medical (Wuxi) Co., Ltd. at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension, Heart Failure
- What is being tested?
- Pulmonary Artery Denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 28 Jun 2024to 15 Jan 2026
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Georgia3 sites
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, K'alak'i T'bilisi, 0112
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, 0159
Tbilisi Heart Center
Tbilisi, K'alak'i T'bilisi, 0186
Singapore1 site
National Heart Centre Singapore
Singapore, Singapore, 169609
About this study
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
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.
- Conditions
- Pulmonary Hypertension, Heart Failure
- Being tested
- Pulmonary Artery Denervation
- Keywords
- Pulmonary Artery Denervation, PADN, Pulmonary Hypertension, Heart Failure
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Artery DenervationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Artery Denervation (PADN) | Experimental | Not described Receives: Procedure: Pulmonary Artery Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance (6MWD) difference
The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start28 Jun 2024
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulnovo Medical (Wuxi) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996562
- Sponsor's protocol ID
- Pulnovo-CO-2023-01
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05996562
- Acronym / sponsor ID
- Pulnovo-CO-2023-01
- Conditions
- Pulmonary Hypertension, Heart Failure
- Keywords
- Pulmonary Artery Denervation, PADN, Pulmonary Hypertension, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pulnovo Medical (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 18 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Artery Denervation (PADN) | Experimental | Procedure: Pulmonary Artery Denervation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18, ≤85 years;
- PH must be confirmed by RHC, defined as:
- 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:
- NYHA class II-IVa;
Key exclusion criteria (27 listed)
- Any of the following:
- 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);
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 DenervationContrast 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. | Procedure or surgery | Pulmonary Artery Denervation (PADN) |
Primary outcome
6-minute walk distance (6MWD) difference
Time frame: 6 months
The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.
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 30 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Artery Denervation in people with Pulmonary Hypertension and Heart Failure, run by Pulnovo Medical (Wuxi) Co., Ltd. at 7 sites in 5 countries.
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 14 inclusion and 27 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Georgia, Italy, Malaysia, Portugal, Singapore. 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?
6-minute walk distance (6MWD) difference (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.