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

Sponsor

Nanjing First Hospital, Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02220335

Collaborator

(none)

Enrollment

Location

Arms

52.7

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Procedure: Pulmonary arterial denervation Drug: Standard treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 8, 2014

Actual Primary Completion Date :

Jun 16, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulmonary Arterial Denervation (PADN) 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.	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. Other Names: PADN 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. Other Names: Diuretics Nitrate esters β-blockers ACE inhibitors or receptor blockers aldosterone antagonists Digoxin
Active Comparator: 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.	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. Other Names: Diuretics Nitrate esters β-blockers ACE inhibitors or receptor blockers aldosterone antagonists Digoxin

Arm

Intervention/Treatment

Experimental: Pulmonary Arterial Denervation (PADN)

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.

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.

Other Names:

PADN

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.

Other Names:

Diuretics

Nitrate esters

β-blockers

ACE inhibitors or receptor blockers aldosterone antagonists

Digoxin

Active Comparator: Standard treatment

Drug: Standard treatment

Other Names:

Diuretics

Nitrate esters

β-blockers

ACE inhibitors or receptor blockers aldosterone antagonists

Digoxin

Outcome Measures

Primary Outcome Measures

6-min-walk distance increase [6 months]
The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.

Secondary Outcome Measures

Pulmonary vascular resistance [6 months]
Measure pulmonary vascular resistance using 2D doppler echocardiogram w/definity. Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.

Other Outcome Measures

Accuracy of pulmonary embolism [6 months]
The safety endpoint is the accuracy of pulmonary embolism (PE). Suspected PE with one of the following: new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; new perfusion defect of at least 75% on V/Q lung scan; inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of deep vein thrombosis in the lower extremities by venography Fatal PE is: PE based on objective diagnostic testing or autopsy or death not attributed to a documented cause and for which deep vein thrombosis/PE cannot be ruled out.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.