Status:
COMPLETED
Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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 gr...
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 r...
Eligibility Criteria
Inclusion
- Age\>18yr
- "Reactive"Pulmonary Hypertension in Left Heart Failure: mPAP≥25 mmHg, PCWP\>15 mmHg and pulmonary vascular resistance (PVR) \[The PVR =(mPAP-PCWP)/ carbon monoxide\]\>3.0 woods unit
- Voluntary acceptance of all follow-up assessment of program requirements.
Exclusion
- WHO group I, III, IV, V pulmonary artery hypertension
- Severe Renal dysfunction (Ccr\<30 ml/min)
- Blood platelet count\<100,000/L
- Expected life span\<12-month
- In pregnancy
- Systematical inflammation
- Malignant cancer(s)
- Tricuspid valve stenosis, Supra-pulmonary valve stenosis
- Allergic to studied drugs or metal materials
Key Trial Info
Start Date :
August 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT02220335
Start Date
August 8 2014
End Date
December 30 2018
Last Update
July 30 2019
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006