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Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension (PADN-CFDA)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PADN
Sham operation
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PADN + 5-phosphodiesterase

Sham operation + 5-phosphodiesterase

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
Change From Baseline in Right Ventricle Functional at 6 Month
Right ventricle functional measures by echocardiography include right ventricle systolic and diastolic functional variables.
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.

Full Information

First Posted
September 12, 2017
Last Updated
March 26, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborators
Pulnovo Medical (Wuxi) Co., Ltd., Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital, First Affiliated Hospital Xi'an Jiaotong University, Beijing Anzhen Hospital, Shenyang Northern Hospital, The Second Affiliated Hospital of Chongqing Medical University, Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03282266
Brief Title
Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
Acronym
PADN-CFDA
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborators
Pulnovo Medical (Wuxi) Co., Ltd., Guangdong Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital, First Affiliated Hospital Xi'an Jiaotong University, Beijing Anzhen Hospital, Shenyang Northern Hospital, The Second Affiliated Hospital of Chongqing Medical University, Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
sham operation
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PADN + 5-phosphodiesterase
Arm Type
Experimental
Arm Description
A total of 64 patients are assigned to PADN + 5-phosphodiesterase group after randomization schedule.
Arm Title
Sham operation + 5-phosphodiesterase
Arm Type
Sham Comparator
Arm Description
A total of 64 patients are assigned to sham operation + 5-phosphodiesterase group after randomization schedule.
Intervention Type
Procedure
Intervention Name(s)
PADN
Other Intervention Name(s)
pulmonary artery denervation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham operation
Intervention Description
The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
Primary Outcome Measure Information:
Title
Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month
Description
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.
Time Frame
Baseline, 6 Month
Secondary Outcome Measure Information:
Title
Change From Baseline in Systolic Pulmonary Arterial Pressure (sPAP) at 6 Month
Description
sPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
Time Frame
Baseline, 6 Month
Title
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at 6 Month
Description
mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
Time Frame
Baseline, 6 Month
Title
Change From Baseline in Cardiac Output (CO) at 6 Month
Description
CO is the volume of blood being pumped by the heart ventricle in the time interval of one minute.
Time Frame
Baseline, 6 Month
Title
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 6 Month
Description
PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
Time Frame
Baseline, 6 Month
Title
Change From Baseline in Pulmonary Vascular Resistance (PVR) at 6 Month
Description
PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).
Time Frame
Baseline, 6 Month
Title
Change From Baseline in Right Ventricle Functional at 6 Month
Description
Right ventricle functional measures by echocardiography include right ventricle systolic and diastolic functional variables.
Time Frame
Baseline, 6 Month
Title
PAH-related events
Description
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.
Time Frame
6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD, PhD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23850902
Citation
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.
Results Reference
background
PubMed Identifier
26553699
Citation
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.
Results Reference
background
PubMed Identifier
36121246
Citation
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.
Results Reference
derived

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

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