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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
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.
The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
Nanjing First Hospital
Nanjing, Jiangsu, China
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.
Time frame: Baseline, 6 Month
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.
Time frame: Baseline, 6 Month
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.
Time frame: Baseline, 6 Month
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.
Time frame: Baseline, 6 Month
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.
Time frame: Baseline, 6 Month
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).
Time frame: Baseline, 6 Month
Change From Baseline in Right Ventricle Functional at 6 Month
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Right ventricle functional measures by echocardiography include right ventricle systolic and diastolic functional variables.
Time frame: Baseline, 6 Month
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.
Time frame: 6 Month