Pulmonary Arterial Hypertension
Conditions
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.
Interventions
PROCEDUREPADN
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.
PROCEDURESham operation
The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
Sponsors
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
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
sham operation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 Right Ventricle Functional at 6 Month | Baseline, 6 Month | Right ventricle functional measures by echocardiography include right ventricle systolic and diastolic functional variables. |
| 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 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). |
Countries
China
Outcome results
None listed