Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure (PADN-5)

Nanjing Medical University

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Drug: Standard treatment; Procedure: Pulmonary arterial denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02220335

20140618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Pulmonary Arterial Denervation (PADN)

Experimental group

Description:

Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes were tightly in contact with the endovascular surface. About four to eight ablations at 10 W for 60 seconds each were performed in ostium of the left PA, ostium of the right PA , and the distal bifurcation area of the main PA.

Treatment:

Procedure: Pulmonary arterial denervation

Drug: Standard treatment

Standard treatment

Active Comparator group

Description:

Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.

Treatment:

Drug: Standard treatment