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

NCT03282266 | Completed DMC

• 1 other identifier: NFH20170501
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (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.

  Baseline, 6 Month

Secondary Outcomes (7)

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

  Baseline, 6 Month

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

  Baseline, 6 Month

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

  Baseline, 6 Month

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

  Baseline, 6 Month

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

  Baseline, 6 Month

Study Arms (2)

PADN + 5-phosphodiesterase

EXPERIMENTAL

A total of 64 patients are assigned to PADN + 5-phosphodiesterase group after randomization schedule.

Procedure: PADN

Sham operation + 5-phosphodiesterase

SHAM COMPARATOR

A total of 64 patients are assigned to sham operation + 5-phosphodiesterase group after randomization schedule.

Procedure: Sham operation

Interventions

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.

Also known as: pulmonary artery denervation

PADN + 5-phosphodiesterase

Sham operation PROCEDURE

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

Sham operation + 5-phosphodiesterase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (3)

• 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.

  PMID: 23850902 BACKGROUND

• 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.

  PMID: 26553699 BACKGROUND

• 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.

  PMID: 36121246 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hang Zhang, MD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: sham operation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Cardiovascular Department

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: January 18, 2018
• Primary Completion: June 22, 2021
• Study Completion: December 22, 2021
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)