Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pulmonary Arterial Hypertension
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: sham operationPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 6M...

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 PAH patients was required, with 64 patients/per group at a ratio of 1:1 randomization.

Tracking Information

NCT #
NCT03282266
Collaborators
  • 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
Investigators
Study Chair: Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University