protocolSection identificationModule nctId: NCT06338839, orgStudyIdInfo id: D8450R00006, briefTitle: Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia, acronym: TETRAMER, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-28, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis, conditionsModule conditions: Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 6000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation, secondaryOutcomes measure: demographic and clinical characteristics, and test results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Akhtubinsk, country: Russian Federation, geoPoint lat: 48.27955, lon: 46.17217, locations facility: Research Site, status: RECRUITING, city: Astrakhan, country: Russian Federation, geoPoint lat: 46.34968, lon: 48.04076, locations facility: Research Site, status: RECRUITING, city: Beslan, country: Russian Federation, geoPoint lat: 43.19217, lon: 44.54313, locations facility: Research Site, status: RECRUITING, city: Izhevsk, country: Russian Federation, geoPoint lat: 56.84976, lon: 53.20448, locations facility: Research Site, status: RECRUITING, city: Kaluga, country: Russian Federation, geoPoint lat: 54.5293, lon: 36.27542, locations facility: Research Site, status: RECRUITING, city: Krasnodar, country: Russian Federation, geoPoint lat: 45.04484, lon: 38.97603, locations facility: Research Site, status: RECRUITING, city: Rostov-on-Don, country: Russian Federation, geoPoint lat: 47.23135, lon: 39.72328, locations facility: Research Site, status: RECRUITING, city: Smolensk, country: Russian Federation, geoPoint lat: 54.7818, lon: 32.0401, locations facility: Research Site, status: RECRUITING, city: Vladimir, country: Russian Federation, geoPoint lat: 56.13655, lon: 40.39658, locations facility: Research Site, status: RECRUITING, city: Vladivostok, country: Russian Federation, geoPoint lat: 43.10562, lon: 131.87353, locations facility: Research Site, status: RECRUITING, city: Volgograd, country: Russian Federation, geoPoint lat: 48.71939, lon: 44.50183, locations facility: Research Site, status: RECRUITING, city: Yaroslavl, country: Russian Federation, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False