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Pulmonary Arterial HypertensionPADN-CFDANCT03282266

Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension

A study testing PADN in people with Pulmonary Arterial Hypertension, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of PADN for the treatment of PAH. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
PADN
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteChina
Study dates
18 Jan 2018to 22 Dec 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedures; Men and women 18 years and older; Group I PAH, defined as a mPAP≥25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.

Who cannot join

  • General exclusion criteria:
  • Pregnancy and breast feeding mother; Estimated life expectancy < 12 months; Scheduled major surgery in the next 6 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.
  • Procedural exclusion criteria:
  • WHO group II, III, IV, V PH Severe Renal dysfunction (Ccr<30 ml/min) Blood platelet count<100,000/L Expected life span<6-month Systematical inflammation Malignant cancer(s) Tricuspid valve stenosis, Supra-pulmonary valve stenosis Allergic to studied drugs or metal materials.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

Other trials in China

About this study

Official title: A Randomised, Single-blind, Sham Operation-controlled Study to Evaluate the Safety and Efficacy of the Pulmonary Artery Denervation for the Treatment of Pulmonary Arterial Hypertension

The objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of PADN for the treatment of PAH.

Read the detailed description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in 6-minute walk distance (6MWD) of PADN on PAH patients. Based on the previous studies, the 6MWD was 13±24 m after 6-month treatment using target drugs. And our previous data showed that 6MWD at 6-month after PADN procedure was 65±85 m. As a result, a total of 128 patients with Group I PAH are randomized at a ratio of 1:1 to either PADN procedure plus phosphodiesterase-5 inhibitors (PDE5i) group (PADN group) or sham-PADN procedure plus PDE5i group (Sham group) using a randomization schedule blocked by site. The combination therapy of PDE5i with additional other PAH-specific target drugs is not recommended for all patients and is left at physician's discretion in both groups.

Being tested
PADN, Sham operation
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

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

  • PADNProcedure or surgery

    Also called pulmonary artery denervation

    PADN was performed at three sites at the conjunctional area between the distal main trunk and the ostial left branch. The following ablation parameters were programmed at each point: a temperature of 45 ℃-50 ℃, energy ≤15 W, and a time of 120 seconds. The procedure would cease for 10 seconds if the patient felt intolerable chest pain during the procedure. The EKG and pressure lines (including cardiac output) were monitored and continuously recorded throughout the procedure.

  • Sham operationProcedure or surgery

    The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.

Study groups in NCT03282266
Study groupRoleWhat they receive
PADN + 5-phosphodiesteraseExperimentalA total of 64 patients are assigned to PADN + 5-phosphodiesterase group after randomization schedule.
Receives: Procedure: PADN
Sham operation + 5-phosphodiesteraseSham comparatorA total of 64 patients are assigned to sham operation + 5-phosphodiesterase group after randomization schedule.
Receives: Procedure: Sham operation

What is being measured

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

  1. Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month

    6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.

    Measured: Baseline, 6 Month

Secondary outcomes (7)

  1. Change From Baseline in Systolic Pulmonary Arterial Pressure (sPAP) at 6 Month

    sPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.

    Measured: Baseline, 6 Month

  2. Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at 6 Month

    mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.

    Measured: Baseline, 6 Month

  3. Change From Baseline in Cardiac Output (CO) at 6 Month

    CO is the volume of blood being pumped by the heart ventricle in the time interval of one minute.

    Measured: Baseline, 6 Month

  4. Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 6 Month

    PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.

    Measured: Baseline, 6 Month

  5. Change From Baseline in Pulmonary Vascular Resistance (PVR) at 6 Month

    PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).

    Measured: Baseline, 6 Month

  6. Change From Baseline in Right Ventricle Functional at 6 Month

    Right ventricle functional measures by echocardiography include right ventricle systolic and diastolic functional variables.

    Measured: Baseline, 6 Month

  7. PAH-related events

    PAH-related events were defined as those caused by worsening of PAH, initiation of treatment with intravenous or subcutaneous prostanoids, lung transplantation, atrial septostomy, or all-cause mortality.

    Measured: 6 Month

Timeline

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

  1. First posted13 Sep 2017
  2. Study start18 Jan 2018
  3. Primary completion22 Jun 2021
  4. Study completion22 Dec 2021

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282266
Sponsor's protocol ID
NFH20170501
Acronym
PADN-CFDA
Status last verified
Sep 2025
First submitted
12 Sep 2017
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen SL, Zhang FF, Xu J, Xie DJ, Zhou L, Nguyen T, Stone GW. Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). J Am Coll Cardiol. 2013 Sep 17;62(12):1092-1100. doi: 10.1016/j.jacc.2013.05.075. Epub 2013 Jul 10.

    PubMed 23850902

  • Chen SL, Zhang H, Xie DJ, Zhang J, Zhou L, Rothman AM, Stone GW. Hemodynamic, functional, and clinical responses to pulmonary artery denervation in patients with pulmonary arterial hypertension of different causes: phase II results from the Pulmonary Artery Denervation-1 study. Circ Cardiovasc Interv. 2015 Nov;8(11):e002837. doi: 10.1161/CIRCINTERVENTIONS.115.002837.

    PubMed 26553699

  • Zhang H, Wei Y, Zhang C, Yang Z, Kan J, Gu H, Fan F, Gu H, Wang Q, Xie D, Zhang G, Guo X, Yin Y, Jin B, Zhou H, Yang Z, Wang Z, Xin Y, Zhang C, Meng L, Wang X, Sun J, Zhao C, Zhang J, Yan X, Chen F, Yao C, Stone GW, Chen SL. Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2412-2423. doi: 10.1016/j.jcin.2022.09.013. Epub 2022 Sep 18.

    PubMed 36121246

Questions about this trial

What is this clinical trial studying?

A study testing PADN in people with Pulmonary Arterial Hypertension, 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 4 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 3 Oct 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. Some participants in this study may receive a placebo. 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?

Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month (time frame: Baseline, 6 Month). 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 NCT03282266, which also lists 3 linked publications.

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 3 Oct 2025.

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