Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-01 @ 11:36 PM
Study NCT ID:
NCT07104968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progress of aortic regurgitation', 'timeFrame': 'Depending on when the patients was evaluated first, up to approximately 20 years of follow-up', 'description': 'Progress of aortic regurgitation from mild to moderate or severe, or moderate to severe. Progress is defined according to current European Society for Cardiology guidelines using a comprehensive echocardiographic assessment'}], 'secondaryOutcomes': [{'measure': 'Surgical treatment of aortic regurgitation or aortic aneurysm', 'timeFrame': 'Depending on when the patients was evaluated first, up to approximately 20 years of follow-up', 'description': 'Surgical treatment of aortic regurgitation or aortic aneurysm'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': 'Depending on when the patients was evaluated first, up to approximately 20 years of follow-up', 'description': 'Hospitalization for heart failure during follow-up'}, {'measure': 'Hospitalization for stroke or myocardial infarction', 'timeFrame': 'Depending on when the patients was evaluated first, up to approximately 20 years of follow-up', 'description': 'Composite endpoint'}, {'measure': 'All-cause mortality', 'timeFrame': 'Depending on when the patients was evaluated first, up to approximately 20 years of follow-up', 'description': 'All-cause mortality during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Regurgitation']}, 'referencesModule': {'references': [{'pmid': '31727286', 'type': 'BACKGROUND', 'citation': 'Yang LT, Enriquez-Sarano M, Michelena HI, Nkomo VT, Scott CG, Bailey KR, Oguz D, Wajih Ullah M, Pellikka PA. Predictors of Progression in Patients With Stage B Aortic Regurgitation. J Am Coll Cardiol. 2019 Nov 19;74(20):2480-2492. doi: 10.1016/j.jacc.2019.08.1058.'}, {'pmid': '10190406', 'type': 'BACKGROUND', 'citation': 'Singh JP, Evans JC, Levy D, Larson MG, Freed LA, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999 Mar 15;83(6):897-902. doi: 10.1016/s0002-9149(98)01064-9.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation', 'detailedDescription': 'Aortic regurgitation is relatively common, with a prevalence of 13% for men and 8,5% for women in the Framingham study (Singh et al). Patients with aortic regurgitation are evaluated regularly with echocardiography to see if progress occurs, and suitable candidates are referred for surgical repair or replacement of the aortic valve.\n\nHowever, an American study from 2019 showed that only 12% of cases of aortic regurgitation progressed from mild to moderate or severe over a 10 years period (Yang et al). This means that the majority of patients undergo echocardiographic evaluations without a clinical benefit.\n\nIt is unclear whether these findings also apply to a Swedish population with the European definitions for aortic regurgitation.\n\nAim:\n\nTo do a retrospective analysis of patients evaluated with echocardiography in Västerås, Sweden between January 2003 and March 2025 to describe the prevalence of aortic regurgitation as well as aortic dilatation, to describe how often progress occurs in patients with mild or moderate aortic regurgitation, and finally to look at factors (clinical, echocardiographic) associated with progress of aortic regurgitation as well as outcome (mortality, MACE, cardiac surgery).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with aortic regurgitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients investigated with echocardiography between January 2003 and March 2025\n* Age ≥18 years\n* At least minimal aortic regurgitation\n* At least one additional echocardiography after the index investigation\n\nExclusion Criteria:\n\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT07104968', 'briefTitle': 'Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome', 'orgStudyIdInfo': {'id': '2025-02671-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with aortic regurgitation', 'description': 'Observational study, no interventions'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Västerås', 'country': 'Sweden', 'contacts': [{'name': 'Matthijs Velders, MD PhD', 'role': 'CONTACT', 'email': 'matthijs.velders@regionvastmanland.se', 'phone': '+4621-175947'}], 'facility': 'Västmanlands sjukhus Västerås', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'centralContacts': [{'name': 'Matthijs Velders, MD PhD', 'role': 'CONTACT', 'email': 'matthijs.velders@regionvastmanland.se', 'phone': '+4621-175947'}], 'overallOfficials': [{'name': 'Matthijs Velders, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Västmanland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Västmanland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Pär Hedberg', 'investigatorAffiliation': 'Region Västmanland'}}}}