Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Pulmonary arterial denervation
- Conditions
- Pulmonary Hypertension
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- 6-min-walk distance increase
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Shaoliang Chen
Vice President
Nanjing First Hospital, Nanjing Medical University
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
Arms & Interventions
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.
Intervention: Pulmonary arterial denervation
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.
Intervention: Standard treatment
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.
Intervention: Standard treatment
Outcomes
Primary Outcomes
6-min-walk distance increase
Time Frame: 6 months
The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.
Secondary Outcomes
- Pulmonary vascular resistance(6 months)