Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Procedure: Sham operationProcedure: PADN
- Registration Number
- NCT03282266
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham operation + 5-phosphodiesterase Sham operation A total of 64 patients are assigned to sham operation + 5-phosphodiesterase group after randomization schedule. PADN + 5-phosphodiesterase PADN A total of 64 patients are assigned to PADN + 5-phosphodiesterase group after randomization schedule.
- Primary Outcome Measures
Name Time Method Change From Baseline in 6-Minute Walk Distance (6MWD) at 6 Month 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 Outcome Measures
Name Time Method Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 6 Month Baseline, 6 Month PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.
Change From Baseline in Cardiac Output (CO) at 6 Month Baseline, 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 Right Ventricle Functional at 6 Month Baseline, 6 Month Right ventricle functional measures by echocardiography include right ventricle systolic and diastolic functional variables.
Change From Baseline in Pulmonary Vascular Resistance (PVR) at 6 Month Baseline, 6 Month PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).
PAH-related events 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.
Change From Baseline in Systolic Pulmonary Arterial Pressure (sPAP) at 6 Month Baseline, 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 Baseline, 6 Month mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.
Trial Locations
- Locations (1)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China