Chart Review of Repatha® in Subjects With Hyperlipidaemia
HEYMANS
Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia
1 other identifier
observational
1,986
12 countries
183
Brief Summary
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJune 6, 2024
June 1, 2024
5.2 years
April 27, 2016
June 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of clinical characteristics of subjects initiated on Repatha®
Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance
Study day 1
Secondary Outcomes (7)
Describe LDL-C and other cholesterol values over time
Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha®
Describe Repatha® dose over time
From the first dose of Repatha® up to 30 months post first dose
Describe use of other lipid-modifying therapies
From the first dose of Repatha® up to 30 months post first dose
Describe Physician visits
From the first dose of Repatha® up to 30 months post first dose
Describe hospitalizations
From the first dose of Repatha® up to 30 months post first dose
- +2 more secondary outcomes
Study Arms (1)
Group 1
To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).
Eligibility Criteria
The study population comprises patients from European countries, who have received Repatha® as part of routine clinical management of their hyperlipidaemia, between August 2015 and June 2021.
You may qualify if:
- Adults (\>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha®
You may not qualify if:
- Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha® Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (183)
Research Site
Feldkirch, 6800, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Klagenfurt, 9020, Austria
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Linz, 4010, Austria
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Salzburg, 5020, Austria
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Vienna, 1060, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Vienna, 1160, Austria
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Villach, 9500, Austria
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Aalst, 9300, Belgium
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Genk, 3600, Belgium
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Ghent, 9000, Belgium
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La Louvière, 7100, Belgium
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Leuven, 3000, Belgium
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Kostenets, 2042, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4003, Bulgaria
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Sofia, 1113, Bulgaria
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Sofia, 1142, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1680, Bulgaria
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Sofia, 1750, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9002, Bulgaria
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Varna, 9020, Bulgaria
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Brno, 656 91, Czechia
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České Budějovice, 370 01, Czechia
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Hradec Králové, 500 05, Czechia
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Liberec, 460 63, Czechia
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Olomouc, 775 20, Czechia
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Pilsen, 305 99, Czechia
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Prague, 140 21, Czechia
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Prague, 150 06, Czechia
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Ústí nad Labem, 401 13, Czechia
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Zlín, 762 75, Czechia
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Aachen, 52074, Germany
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Bad Reichenhall, 83435, Germany
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Berlin, 12627, Germany
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Berlin, 13353, Germany
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Bielefeld, 33602, Germany
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Bochum, 44787, Germany
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Borsdorf, 04451, Germany
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Detmold, 32756, Germany
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Garbsen, 30823, Germany
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Germering, 82110, Germany
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Göttingen, 37075, Germany
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Halberstadt, 38820, Germany
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Halle, 06120, Germany
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Hamburg, 20095, Germany
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Langenhagen, 30851, Germany
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Leipzig, 04317, Germany
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Mainz, 55131, Germany
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Mannheim, 68165, Germany
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Markleeberg, 04416, Germany
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Mönchengladbach, 41063, Germany
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Mühldorf, 84453, Germany
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Mülheim, 45468, Germany
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München, 80331, Germany
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München, 80638, Germany
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Neuwied, 56564, Germany
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Nuremberg, 90443, Germany
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Oschatz, 04758, Germany
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Pirna, 01796, Germany
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Potsdam, 14471, Germany
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Rostock, 18059, Germany
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Rotenburg (Wümme), 27356, Germany
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Viersen-Dülken, 41751, Germany
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Villingen-Schwenningen, 78052, Germany
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Zwickau, 08060, Germany
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Alexandroupoli, 68100, Greece
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Athens, 10676, Greece
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Athens, 11521, Greece
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Athens, 11526, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Athens, 14233, Greece
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Athens, 14561, Greece
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Athens, 16673, Greece
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Athens, 17674, Greece
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Heraklion, 71110, Greece
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Ioannina, 45500, Greece
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Larissa, 41110, Greece
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Piraeus, 18536, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 56403, Greece
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Thessaloniki, 56429, Greece
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Acerra, Italy
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Arzignano, 36071, Italy
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Asti, 14100, Italy
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Bassano Del Grappa (VI), 36061, Italy
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Bologna, 40133, Italy
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Brescia, 25123, Italy
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Brindisi, 72100, Italy
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Catanzaro, 88100, Italy
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Cinisello Balsamo (MI), 20092, Italy
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Cona FE, 44124, Italy
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Cosenza, 87100, Italy
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Foggia, 71100, Italy
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Lido Di Camaiore LU, 55041, Italy
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Messina, 89125, Italy
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Mestre (VE), 30174, Italy
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Milan, 20132, Italy
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Milan, 20138, Italy
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Milan, 20142, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Palermo, 90127, Italy
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Pescara, 65100, Italy
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Reggio Calabria, 89124, Italy
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Rivoli, 10098, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Salerno, 84131, Italy
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Seriate, 24068, Italy
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Sesto San Giovanni (MI), 20099, Italy
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Taranto, 74100, Italy
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Torrette Di Ancona, 60126, Italy
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Treviglio (BG), 24047, Italy
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Trieste, 34125, Italy
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Almada, 2801-951, Portugal
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Carnaxide, 2790-134, Portugal
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Coimbra, 3000-075, Portugal
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Faro, 8000-386, Portugal
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Matosinhos Municipality, 4464-513, Portugal
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Porto, 4099-001, Portugal
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Banská Bystrica, 974 01, Slovakia
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Bratislava, 813 69, Slovakia
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Bratislava, 826 06, Slovakia
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Bratislava, 831 01, Slovakia
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Bratislava, 831 06, Slovakia
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Bratislava, 833 48, Slovakia
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Brezno, 977 42, Slovakia
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Handlová, 972 51, Slovakia
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Komárno, 945 01, Slovakia
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Košice, 040 01, Slovakia
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Košice, 040 22, Slovakia
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Martin, 036 01, Slovakia
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Martin, 036 59, Slovakia
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Moldava nad Bodvou, 045 01, Slovakia
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Myjava, 907 01, Slovakia
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Námestovo, 029 01, Slovakia
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Nitra, 949 01, Slovakia
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Nitra, 949 88, Slovakia
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Nitra, 950 01, Slovakia
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Nové Mesto nad Váhom, 915 01, Slovakia
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Nové Zámky, 940 01, Slovakia
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Poprad, 058 01, Slovakia
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Prešov, 080 01, Slovakia
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Rožňava, 048 01, Slovakia
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Trnava, 917 01, Slovakia
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Žilina, 010 01, Slovakia
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Cadiz, Andalusia, 11009, Spain
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Huelva, Andalusia, 21080, Spain
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Jaén, Andalusia, 23007, Spain
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Málaga, Andalusia, 29010, Spain
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Seville, Andalusia, 41009, Spain
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Seville, Andalusia, 41013, Spain
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Palma de Mallorca, Balearic Islands, 07010, Spain
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Badalona, Catalonia, 08916, Spain
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Barcelona, Catalonia, 08041, Spain
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Reus, Catalonia, 43204, Spain
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Sabadell, Catalonia, 08208, Spain
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Ferrol, Galicia, 15405, Spain
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Lugo, Galicia, 27003, Spain
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Alcalá de Henares, Madrid, 28805, Spain
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Madrid, 28006, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Gothenburg, 413 45, Sweden
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Malmo, 205 02, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 751 85, Sweden
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Basel, 4031, Switzerland
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Geneva, 1211, Switzerland
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Lugano, 6900, Switzerland
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Winterthur, 8401, Switzerland
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Zurich, 8063, Switzerland
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Zurich, 8091, Switzerland
Related Publications (7)
Ray KK, Dhalwani N, Sibartie M, Bridges I, Ebenbichler C, Perrone-Filardi P, Villa G, Vogt A, Bruckert E. Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study. Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):447-460. doi: 10.1093/ehjqcco/qcac009.
PMID: 35175350BACKGROUNDBlaha V, Margoczy R, Petrov I, Postadzhiyan A, Raslova K, Rosolova H, Bridges I, Dhalwani NN, Zachlederova M, Ray KK. Evolocumab is Initiated in Central and Eastern Europe at Much Higher LDL-C Levels Than Recommended in Guidelines: Results from the Observational HEYMANS Study. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231172847. doi: 10.1177/10742484231172847.
PMID: 37218974BACKGROUNDBlanco Echevarria A, Garcia Diaz JD, Caixas A, Plana Gil N, Rico Corral MA, Bridges I, Dhalwani N, Gatell Menchen S, Ray KK. Long-term treatment persistence and maintained reduction of LDL-cholesterol levels with evolocumab over 30 months: Results from the Spanish cohort of the European prospective HEYMANS study. Clin Investig Arterioscler. 2023 Nov-Dec;35(6):263-271. doi: 10.1016/j.arteri.2023.04.004. Epub 2023 May 24. English, Spanish.
PMID: 37236829BACKGROUNDEbenbichler C, Drexel H, Hanusch U, Toplak H, Dhalwani NN, Bridges I, Hoelzl R, Hemetsberger M, Ray KK. Evolocumab effectiveness in the real-world setting: Austrian data from the pan-European observational HEYMANS study. Wien Klin Wochenschr. 2024 Feb;136(3-4):77-86. doi: 10.1007/s00508-023-02245-w. Epub 2023 Jul 31.
PMID: 37525072BACKGROUNDSudano I, Krahenbuhl S, Mach F, Anstett A, Dhalwani N, Bridges I, Sibartie M, Ray KK. Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study. Ther Adv Cardiovasc Dis. 2024 Jan-Dec;18:17539447231213288. doi: 10.1177/17539447231213288.
PMID: 38183273BACKGROUNDLehrke M, Vogt A, Schettler V, Girndt M, Fraass U, Tabbert-Zitzler A, Bridges I, Dhalwani NN, Ray KK. Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study. Adv Ther. 2024 Mar;41(3):1184-1200. doi: 10.1007/s12325-023-02757-x. Epub 2024 Jan 30.
PMID: 38286961BACKGROUNDVlachopoulos C, Massia D, Kochiadakis G, Kolovou G, Patsilinakos S, Bridges I, Sibartie M, Dhalwani NN, Liberopoulos E, Ray KK. Evolocumab use in Greece is associated with early and sustainable reductions in low-density cholesterol (LDL-C) and high persistence to therapy: Results from the Greek cohort analysis of the observational HEYMANS study. Hellenic J Cardiol. 2023 Nov-Dec;74:74-76. doi: 10.1016/j.hjc.2023.09.003. Epub 2023 Sep 18. No abstract available.
PMID: 37730147BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 12, 2016
Study Start
May 4, 2016
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
June 6, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request