Pulmonary Hypertension
Conditions
Keywords
pulmonary hypertension, pulmonary arterial denervation, left heart failure, 6-min walk distance
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.
Interventions
PROCEDUREPulmonary 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.
DRUGStandard 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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18yr * ReactivePulmonary 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of pulmonary embolism | 6 months | The safety endpoint is the accuracy of pulmonary embolism (PE). Suspected PE with one of the following: 1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; 2. new perfusion defect of at least 75% on V/Q lung scan; 3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of deep vein thrombosis in the lower extremities by venography Fatal PE is: 1. PE based on objective diagnostic testing or autopsy or 2. death not attributed to a documented cause and for which deep vein thrombosis/PE cannot be ruled out. |
Countries
China
Outcome results
None listed