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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03282266
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact
Status Completed
Phase N/A
Start date January 18, 2018
Completion date December 22, 2021
View Details
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