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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
sham operation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 6 Month(Baseline, 6 Month)
- Change From Baseline in Cardiac Output (CO) at 6 Month(Baseline, 6 Month)
- Change From Baseline in Right Ventricle Functional at 6 Month(Baseline, 6 Month)
- Change From Baseline in Pulmonary Vascular Resistance (PVR) at 6 Month(Baseline, 6 Month)
- PAH-related events(6 Month)
- 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)
Investigators
Hang Zhang
Vice Director of Cardiovascular Department
Nanjing First Hospital, Nanjing Medical University