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

NCT02220335 | Completed DMC

• 1 other identifier: 20140618
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; pulmonary arterial denervation; left heart failure; 6-min walk distance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pulmonary vascular resistance

  6 months

Other Outcomes (1)

• Accuracy of pulmonary embolism

  6 months

Study Arms (2)

Pulmonary Arterial Denervation (PADN)

EXPERIMENTAL

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; Drug: Standard treatment

Standard treatment

ACTIVE COMPARATOR

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

Interventions

Pulmonary arterial denervation PROCEDURE

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.

Also known as: PADN

Pulmonary Arterial Denervation (PADN)

Standard treatment DRUG

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.

Also known as: Diuretics, Nitrate esters, β-blockers, ACE inhibitors or receptor blockers aldosterone antagonists, Digoxin

Pulmonary Arterial Denervation (PADN); Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (2)

• Zhang H, Kan J, Zhang J, Xie D, Li X, Zhou W, Dong J, Gu H, Han Y, Chen SL. 3-Year Outcome in Patients With Combined Precapillary and Postcapillary Pulmonary Hypertension: Results From PADN-5 Trial. JACC Heart Fail. 2023 Aug;11(8 Pt 2):1135-1146. doi: 10.1016/j.jchf.2023.05.016. Epub 2023 Jun 21.

  PMID: 37354146 DERIVED

• Zhang H, Zhang J, Chen M, Xie DJ, Kan J, Yu W, Li XB, Xu T, Gu Y, Dong J, Gu H, Han Y, Chen SL. Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study. JACC Cardiovasc Interv. 2019 Feb 11;12(3):274-284. doi: 10.1016/j.jcin.2018.09.021. Epub 2018 Oct 23.

  PMID: 30732732 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Heart Failure

Interventions

Diuretics; Angiotensin-Converting Enzyme Inhibitors; Digoxin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Shaoliang Chen, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 19, 2014
• Study Start: August 8, 2014
• Primary Completion: June 16, 2018
• Study Completion: December 30, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)