Hypercholesterolaemia Clinical Trial
— HEYMANSOfficial title:
Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia
| NCT number | NCT02770131 |
| Other study ID # | 20130296 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 4, 2016 |
| Est. completion date | June 30, 2021 |
| Verified date | June 2024 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.
| Status | Completed |
| Enrollment | 1986 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | June 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | Inclusion Criteria: Adults (>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha® Exclusion Criteria: 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® |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Feldkirch | |
| Austria | Research Site | Graz | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Klagenfurt | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Salzburg | |
| Austria | Research Site | Villach | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wien | |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | La Louvière | |
| Belgium | Research Site | Leuven | |
| Bulgaria | Research Site | Kostenets | |
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Stara Zagora | |
| Bulgaria | Research Site | Varna | |
| Bulgaria | Research Site | Varna | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Ceske Budejovice | |
| Czechia | Research Site | Hradec Kralove | |
| Czechia | Research Site | Liberec | |
| Czechia | Research Site | Olomouc | |
| Czechia | Research Site | Plzen | |
| Czechia | Research Site | Praha 4 | |
| Czechia | Research Site | Praha 5 | |
| Czechia | Research Site | Usti nad Labem | |
| Czechia | Research Site | Zlin | |
| Germany | Research Site | Aachen | |
| Germany | Research Site | Bad Reichenhall | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bielefeld | |
| Germany | Research Site | Bochum | |
| Germany | Research Site | Borsdorf | |
| Germany | Research Site | Detmold | |
| Germany | Research Site | Garbsen | |
| Germany | Research Site | Germering | |
| Germany | Research Site | Göttingen | |
| Germany | Research Site | Halberstadt | |
| Germany | Research Site | Halle (Saale) | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Langenhagen | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Markleeberg | |
| Germany | Research Site | Mönchengladbach | |
| Germany | Research Site | Muenchen | |
| Germany | Research Site | Mühldorf | |
| Germany | Research Site | Mülheim an der Ruhr | |
| Germany | Research Site | München | |
| Germany | Research Site | München | |
| Germany | Research Site | Neuwied | |
| Germany | Research Site | Nürnberg | |
| Germany | Research Site | Oschatz | |
| Germany | Research Site | Pirna | |
| Germany | Research Site | Potsdam | |
| Germany | Research Site | Rostock | |
| Germany | Research Site | Rotenburg | |
| Germany | Research Site | Viersen-Dülken | |
| Germany | Research Site | Villingen-Schwenningen | |
| Germany | Research Site | Zwickau | |
| Greece | Research Site | Alexandroupoli | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Greece | Research Site | Ioannina | |
| Greece | Research Site | Larissa | |
| Greece | Research Site | Piraeus | |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Thessaloniki | |
| Italy | Research Site | Acerra | |
| Italy | Research Site | Arzignano | |
| Italy | Research Site | Asti | |
| Italy | Research Site | Bassano Del Grappa (VI) | |
| Italy | Research Site | Bologna | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Brindisi | |
| Italy | Research Site | Catanzaro | |
| Italy | Research Site | Cinisello Balsamo (MI) | |
| Italy | Research Site | Cona FE | |
| Italy | Research Site | Cosenza | |
| Italy | Research Site | Foggia | |
| Italy | Research Site | Lido Di Camaiore LU | |
| Italy | Research Site | Messina | |
| Italy | Research Site | Mestre (VE) | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Palermo | |
| Italy | Research Site | Pescara | |
| Italy | Research Site | Reggio Calabria | |
| Italy | Research Site | Rivoli | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Salerno | |
| Italy | Research Site | Seriate | |
| Italy | Research Site | Sesto San Giovanni (MI) | |
| Italy | Research Site | Taranto | |
| Italy | Research Site | Torrette Di Ancona | |
| Italy | Research Site | Treviglio (BG) | |
| Italy | Research Site | Trieste | |
| Portugal | Research Site | Almada | |
| Portugal | Research Site | Carnaxide | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Faro | |
| Portugal | Research Site | Matosinhos | |
| Portugal | Research Site | Porto | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Brezno | |
| Slovakia | Research Site | Handlova | |
| Slovakia | Research Site | Komarno | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Martin | |
| Slovakia | Research Site | Martin | |
| Slovakia | Research Site | Moldava nad Bodvou | |
| Slovakia | Research Site | Myjava | |
| Slovakia | Research Site | Namestovo | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Nove Mesto nad Vahom | |
| Slovakia | Research Site | Nove Zamky | |
| Slovakia | Research Site | Poprad | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Roznava | |
| Slovakia | Research Site | Trnava | |
| Slovakia | Research Site | Zilina | |
| Spain | Research Site | Alcala de Henares | Madrid |
| Spain | Research Site | Badalona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Cadiz | Andalucía |
| Spain | Research Site | Ferrol | Galicia |
| Spain | Research Site | Huelva | Andalucía |
| Spain | Research Site | Jaen | Andalucía |
| Spain | Research Site | Lugo | Galicia |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Malaga | Andalucía |
| Spain | Research Site | Palma de Mallorca | Baleares |
| Spain | Research Site | Reus | Cataluña |
| Spain | Research Site | Sabadell | Cataluña |
| Spain | Research Site | Sevilla | Andalucía |
| Spain | Research Site | Sevilla | Andalucía |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Malmo | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Switzerland | Research Site | Basel | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | Lugano | |
| Switzerland | Research Site | Winterthur | |
| Switzerland | Research Site | Zurich | |
| Switzerland | Research Site | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Austria, Belgium, Bulgaria, Czechia, Germany, Greece, Italy, Portugal, Slovakia, Spain, Sweden, Switzerland,
Blaha 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. — View Citation
Blanco 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. — View Citation
Ebenbichler 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. — View Citation
Lehrke 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. — View Citation
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. — View Citation
Sudano 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. — View Citation
Vlachopoulos 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Describe LDL-C and other cholesterol values over time | Detail all cholesterol assessments recorded during the observation period (Total Cholesterol, LDL-C, HDL-C, Non-HDL-C and Triglycerides). | Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha® | |
| Secondary | Describe Repatha® dose over time | Record Repatha® dose in mg | From the first dose of Repatha® up to 30 months post first dose | |
| Secondary | Describe use of other lipid-modifying therapies | Describe lipid-modifying therapies over time, type, dose and dose frequency during the observation period | From the first dose of Repatha® up to 30 months post first dose | |
| Secondary | Describe Physician visits | Collection of all primary and secondary healthcare visit dates and classification as to cardiovascular and non-cardiovascular. | From the first dose of Repatha® up to 30 months post first dose | |
| Secondary | Describe hospitalizations | Detail all hospitalizations from enrolment to end of study | From the first dose of Repatha® up to 30 months post first dose | |
| Secondary | Describe Repatha® dose frequency over time | Record dose frequency (Q2W, QM) | From the first dose of Repatha® up to 30 months post first dose | |
| Secondary | Describe Repatha® administrative device use over time | Record Repatha® administration device details, personal injector, autoinjector or pre-filled syringe throughout the observation period | From the first dose of Repatha® up to 30 months post first dose |
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