NCT02220335

Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure

Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Pulmonary arterial denervation	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 the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.
DRUG	Standard treatment	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.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.

Timeline

• Start date: 2014-08-08
• Primary completion: 2018-06-16
• Completion: 2018-12-30
• First posted: 2014-08-19
• Last updated: 2019-07-30

Locations

1 site across 1 country: China