Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-26 @ 12:27 AM
Study NCT ID:
NCT02220335
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2014-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accuracy of pulmonary embolism', 'timeFrame': '6 months', 'description': 'The safety endpoint is the accuracy of pulmonary embolism (PE). Suspected PE with one of the following:\n\n1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram;\n2. new perfusion defect of at least 75% on V/Q lung scan;\n3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of deep vein thrombosis in the lower extremities by venography\n\nFatal PE is:\n\n1. PE based on objective diagnostic testing or autopsy or\n2. death not attributed to a documented cause and for which deep vein thrombosis/PE cannot be ruled out.'}], 'primaryOutcomes': [{'measure': '6-min-walk distance increase', 'timeFrame': '6 months', 'description': 'The primary effectiveness endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6 months post-randomization.'}], 'secondaryOutcomes': [{'measure': 'Pulmonary vascular resistance', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pulmonary hypertension', 'pulmonary arterial denervation', 'left heart failure', '6-min walk distance'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '37354146', 'type': 'DERIVED', 'citation': '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': '30732732', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll the "reactive" pulmonary hypertension patients are eligible for the randomized study in PADN group or control group according to the computer generated random table.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18yr\n* "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\n* Voluntary acceptance of all follow-up assessment of program requirements.\n\nExclusion Criteria:\n\n* WHO group I, III, IV, V pulmonary artery hypertension\n* Severe Renal dysfunction (Ccr\\<30 ml/min)\n* Blood platelet count\\<100,000/L\n* Expected life span\\<12-month\n* In pregnancy\n* Systematical inflammation\n* Malignant cancer(s)\n* Tricuspid valve stenosis, Supra-pulmonary valve stenosis\n* Allergic to studied drugs or metal materials'}, 'identificationModule': {'nctId': 'NCT02220335', 'acronym': 'PADN-5', 'briefTitle': 'Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '20140618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary Arterial Denervation (PADN)', 'description': '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.', 'interventionNames': ['Procedure: Pulmonary arterial denervation', 'Drug: Standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': '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.', 'interventionNames': ['Drug: Standard treatment']}], 'interventions': [{'name': 'Pulmonary arterial denervation', 'type': 'PROCEDURE', 'otherNames': ['PADN'], 'description': '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.', 'armGroupLabels': ['Pulmonary Arterial Denervation (PADN)']}, {'name': 'Standard treatment', 'type': 'DRUG', 'otherNames': ['Diuretics', 'Nitrate esters', 'β-blockers', 'ACE inhibitors or receptor blockers aldosterone antagonists', 'Digoxin'], 'description': "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.", 'armGroupLabels': ['Pulmonary Arterial Denervation (PADN)', 'Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Shaoliang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Shaoliang Chen', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}