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

Pulmonary Hypertension Clinical Trial

— PADN-5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220335
• Other study ID #: 20140618
• Status: Completed
• Phase: N/A
• Start date: August 8, 2014
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 30, 2018
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of pulmonary embolism	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.	6 months
Primary	6-min-walk distance increase	The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.	6 months
Secondary	Pulmonary vascular resistance	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.	6 months