Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-25 @ 7:21 PM
Study NCT ID:
NCT02220335
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2014-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure
Sponsor:
Nanjing First Hospital, Nanjing Medical University
Organization:
Study Overview
Official Title:
Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PADN-5
Brief Summary:
A number of 100 patients with pulmonary hypertension associated with the left Heart failure scheduled for elective pulmonary arterial denervation (PADN) are randomized 1:1 to either PADN or control group.
Detailed Description:
Heart failure patients must have completed the right heart catheterization. All the patients accepted the optimal medical therapies,including diuretics, Nitrate esters, β-blockers, ACE inhibitors or receptor blocker aldosterone antagonists and/or digoxin).The patients of pulmonary hypertension are defined into two groups: "passive" pulmonary hypertension(mPAP≥25 mmHg, PCWP\>15 mmHg and pulmonary vascular resistance\<3 woods unit) increase due to backward transmission of increased left ventricular filling pressure, "reactive" pulmonary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg and pulmonary vascular resistance \>3 woods unit) increase in resistance due to either pulmonary vasoconstriction or structural changes in the pulmonary vasculature.
All the "reactive" pulmonary hypertension patients are eligible for the randomized study in PADN group or control group according to the computer generated random table.
All the "reactive" pulmonary hypertension patients are eligible for the randomized study in PADN group or control group according to the computer generated random table.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: