Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT04117659
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2019-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058986', 'term': 'Phosphodiesterase 5 Inhibitors'}], 'ancestors': [{'id': 'D010726', 'term': 'Phosphodiesterase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'withdrawal of a pharmacologic therapy in pre-treated patients without control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in right ventricular global longitudinal strain', 'timeFrame': '4 weeks after discontinuation of phosphodiesterase-5 inhibitors', 'description': 'Change in right ventricular function from baseline as assessed by global longitudinal strain of the right ventricle on transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in peak oxygen uptake rate', 'timeFrame': '4 weeks after discontinuation of phosphodiesterase-5 inhibitors', 'description': 'Change from baseline in functional status as estimated by peak oxygen uptake rate in cardiopulmonary exercise testing'}, {'measure': 'Change from baseline in 6-minute walking distance', 'timeFrame': '4 weeks after discontinuation of phosphodiesterase-5 inhibitors', 'description': 'Change from baseline in walking distance assessed by 6-minute walking test'}, {'measure': 'Change from baseline in the total score of quality of life calculated with the Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '4 weeks after discontinuation of phosphodiesterase-5 inhibitors', 'description': 'Change from baseline in the total score calculated with the Kansas City Cardiomyopathy Questionnaire (range between 0 and 100, higher value indicates worse status of quality of life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Left ventricular assist device', 'postoperative right heart failure'], 'conditions': ['Phosphodiesterase Inhibitor Adverse Reaction', 'Right-Sided Heart Failure']}, 'referencesModule': {'references': [{'pmid': '15620942', 'type': 'BACKGROUND', 'citation': 'Trachte AL, Lobato EB, Urdaneta F, Hess PJ, Klodell CT, Martin TD, Staples ED, Beaver TM. Oral sildenafil reduces pulmonary hypertension after cardiac surgery. Ann Thorac Surg. 2005 Jan;79(1):194-7; discussion 194-7. doi: 10.1016/j.athoracsur.2004.06.086.'}, {'pmid': '20132950', 'type': 'BACKGROUND', 'citation': 'Kormos RL, Teuteberg JJ, Pagani FD, Russell SD, John R, Miller LW, Massey T, Milano CA, Moazami N, Sundareswaran KS, Farrar DJ; HeartMate II Clinical Investigators. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes. J Thorac Cardiovasc Surg. 2010 May;139(5):1316-24. doi: 10.1016/j.jtcvs.2009.11.020. Epub 2010 Feb 4.'}, {'pmid': '24689700', 'type': 'BACKGROUND', 'citation': 'Hamdan R, Mansour H, Nassar P, Saab M. Prevention of right heart failure after left ventricular assist device implantation by phosphodiesterase 5 inhibitor. Artif Organs. 2014 Nov;38(11):963-7. doi: 10.1111/aor.12277. Epub 2014 Apr 2.'}, {'pmid': '26043796', 'type': 'BACKGROUND', 'citation': 'Baker WL, Radojevic J, Gluck JA. Systematic Review of Phosphodiesterase-5 Inhibitor Use in Right Ventricular Failure Following Left Ventricular Assist Device Implantation. Artif Organs. 2016 Feb;40(2):123-8. doi: 10.1111/aor.12518. Epub 2015 Jun 4.'}, {'pmid': '17184632', 'type': 'BACKGROUND', 'citation': 'Klodell CT Jr, Morey TE, Lobato EB, Aranda JM Jr, Staples ED, Schofield RS, Hess PJ, Martin TD, Beaver TM. Effect of sildenafil on pulmonary artery pressure, systemic pressure, and nitric oxide utilization in patients with left ventricular assist devices. Ann Thorac Surg. 2007 Jan;83(1):68-71; discussion 71. doi: 10.1016/j.athoracsur.2006.08.051.'}, {'pmid': '19808294', 'type': 'BACKGROUND', 'citation': 'Tedford RJ, Hemnes AR, Russell SD, Wittstein IS, Mahmud M, Zaiman AL, Mathai SC, Thiemann DR, Hassoun PM, Girgis RE, Orens JB, Shah AS, Yuh D, Conte JV, Champion HC. PDE5A inhibitor treatment of persistent pulmonary hypertension after mechanical circulatory support. Circ Heart Fail. 2008 Nov;1(4):213-9. doi: 10.1161/CIRCHEARTFAILURE.108.796789.'}, {'pmid': '23352391', 'type': 'BACKGROUND', 'citation': 'Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA, Morgan JA, Arabia F, Bauman ME, Buchholz HW, Deng M, Dickstein ML, El-Banayosy A, Elliot T, Goldstein DJ, Grady KL, Jones K, Hryniewicz K, John R, Kaan A, Kusne S, Loebe M, Massicotte MP, Moazami N, Mohacsi P, Mooney M, Nelson T, Pagani F, Perry W, Potapov EV, Eduardo Rame J, Russell SD, Sorensen EN, Sun B, Strueber M, Mangi AA, Petty MG, Rogers J; International Society for Heart and Lung Transplantation. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013 Feb;32(2):157-87. doi: 10.1016/j.healun.2012.09.013. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Refractory right heart failure is common during the postoperative period after left ventricular assist device implantation. Oral phosphodiesterase-5 inhibitors are oft initiated in order to facilitate weaning from the intravenous inotropic substances. following this period many patients continue to receive the same medication in the long term, despite missing data on its therapeutic effect on right ventricular function.We hypothesise that beyond the acute postoperative period no additional benefit from the phosphodiesterase-5 inhibitors exists. The aim of the study is a detailed clinical and echocardiographic assessment of the right ventricular function after discontinuation of the medication in patients pretreated for at least one month after receiving left ventricular assist device.', 'detailedDescription': 'The study aims to assess clinical and echocardiographic measures of right ventricular function before and after discontinuation of the oral phosphodiesterase-5 inhibitor in patients on left ventricular device support. At baseline and after discontinuation of the medication patients will receive a clinical examination and New York Heart Association Classification, echocardiographic assessment of right ventricular function, cardiopulmonary exercise testing, 6 minute walking test and assessment of quality of life. The primary outcome is the change of the quantitative echocardiographic parameters of right ventricular function at follow-up. Secondarily, we aim to assess the change in cardiopulmonary exercise capacity, the 6-minute walking distance and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 y.o.\n* clinically stable, ambulatory heart failure patients on left ventricular assist device support\n* implantation \\> 1 month before inclusion in the study\n* uninterrupted therapy with an oral phosphodiesterase-5 inhibitor initiated during the early postoperativ period due to right heart failure\n\nExclusion Criteria:\n\n* unable to provide written informed consent\n* refusal to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04117659', 'acronym': 'PIVAD', 'briefTitle': 'Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Right Ventricular Function After Withdrawal of Phosphodiesterase-5 Inhibitors in Left Ventricular Assist Device Recipients', 'orgStudyIdInfo': {'id': '177923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phosphodiesterase-5 inhibitor withdrawal', 'description': 'In this single arm pretreatment with an oral phosphodiesterase-5 inhibitor will be discontinued', 'interventionNames': ['Other: withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients']}], 'interventions': [{'name': 'withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients', 'type': 'OTHER', 'description': 'discontinuation of the oral medication with a phosphodiesterase-5 inhibitor', 'armGroupLabels': ['Phosphodiesterase-5 inhibitor withdrawal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Maria Papathanasiou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Essen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Cardiologist', 'investigatorFullName': 'Maria Papathanasiou', 'investigatorAffiliation': 'University Hospital, Essen'}}}}