Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02284737
Status:
TERMINATED
Last Update Posted:
2024-02-20
First Post:
2014-10-28
Brief Title:
A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
A Prospective Multi-center Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery Hypertension
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PADN-PAH
Brief Summary:
Pulmonary arterial hypertension PAH is characterized by premature death mainly because of progressive and severe right ventricular failure Target drugs are reported to be associated with significant improvement of clinical outcome for PAH patients However previous studies using those target drugs focused on the change of 6-minute walk distance 6MWD and or hemodynamic responses As 6MWD has weak correlation with clinical outcome time to clinical worsening TTCW benefits from target drugs for PAH patients are not clear We previously reported the safety and efficacy of pulmonary artery denervation PADN for treatment of PAH patients who were unresponsive to target drugs Hence we design the randomized study to identify the effect of PADN on PAH
Detailed Description:
The current study is designed as a multicenter randomized and prospective study aiming to compare the effect of PADN on PAH patients Based on the previous studies the rate of pulmonary arterial hypertension PAH-related event was around 30 after 6-month treatment using target drugs And our previous data showed that this PAH-related event at 6-month after PADN procedure was 15 As a result a total of 270 PAH patients was required with 135 patientsper group at a ratio of 11 randomization All patients underwent an 18F-DOPA PETCT scan of pulmonary arteries and the heart performed at basement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None