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NCT Number: NCT03282266

Safety and Efficacy of Pulmonary Artery Denervation in Patients With 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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

PADN

Procedure

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.

Other names: pulmonary artery denervation

Sham operation

Procedure

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

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, 6 Month

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

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

    Time frame: Baseline, 6 Month

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

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

    Time frame: Baseline, 6 Month

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

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

    Time frame: Baseline, 6 Month

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

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

    Time frame: Baseline, 6 Month

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

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

    Time frame: Baseline, 6 Month

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

  7. PAH-related events

    Time frame: 6 Month

    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.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Collaborators

  • Beijing Anzhen Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Guangdong Provincial People's Hospital
  • Pulnovo Medical (Wuxi) Co., Ltd.
  • Shenyang Northern Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The Second Affiliated Hospital of Chongqing Medical University
  • Tianjin Medical University General Hospital
  • Tongji Hospital

Registry information

Official study 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

Acronym: PADN-CFDA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2017
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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