Clinical trial NCT02220335: Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure
Official title: Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
pulmonary arterial denervation
left heart failure
6-min walk distance
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: 6-min-walk distance increase
timeFrame: 6 months
Secondary outcomes:
measure: Pulmonary vascular resistance
timeFrame: 6 months
Other outcomes:
measure: Accuracy of pulmonary embolism
timeFrame: 6 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shaoliang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang H, Zhang J, Chen M, Xie DJ, Kan J, Yu W, Li XB, Xu T, Gu Y, Dong J, Gu H, Han Y, Chen SL. Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study. JACC Cardiovasc Interv. 2019 Feb 11;12(3):274-284. doi: 10.1016/j.jcin.2018.09.021. Epub 2018 Oct 23.