Chart Review of Repatha® in Subjects With Hyperlipidaemia (HEYMANS)
June 4, 2024 updated by: Amgen
Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1986
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Feldkirch, Austria, 6800
- Research Site
-
Graz, Austria, 8036
- Research Site
-
Innsbruck, Austria, 6020
- Research Site
-
Klagenfurt, Austria, 9020
- Research Site
-
Linz, Austria, 4010
- Research Site
-
Salzburg, Austria, 5020
- Research Site
-
Villach, Austria, 9500
- Research Site
-
Wien, Austria, 1130
- Research Site
-
Wien, Austria, 1090
- Research Site
-
Wien, Austria, 1160
- Research Site
-
Wien, Austria, 1060
- Research Site
-
-
-
-
-
Aalst, Belgium, 9300
- Research Site
-
Genk, Belgium, 3600
- Research Site
-
Gent, Belgium, 9000
- Research Site
-
La Louvière, Belgium, 7100
- Research Site
-
Leuven, Belgium, 3000
- Research Site
-
-
-
-
-
Kostenets, Bulgaria, 2042
- Research Site
-
Pleven, Bulgaria, 5800
- Research Site
-
Plovdiv, Bulgaria, 4003
- Research Site
-
Plovdiv, Bulgaria, 4000
- Research Site
-
Sofia, Bulgaria, 1407
- Research Site
-
Sofia, Bulgaria, 1527
- Research Site
-
Sofia, Bulgaria, 1750
- Research Site
-
Sofia, Bulgaria, 1142
- Research Site
-
Sofia, Bulgaria, 1309
- Research Site
-
Sofia, Bulgaria, 1113
- Research Site
-
Sofia, Bulgaria, 1680
- Research Site
-
Stara Zagora, Bulgaria, 6003
- Research Site
-
Varna, Bulgaria, 9002
- Research Site
-
Varna, Bulgaria, 9020
- Research Site
-
-
-
-
-
Brno, Czechia, 656 91
- Research Site
-
Ceske Budejovice, Czechia, 370 01
- Research Site
-
Hradec Kralove, Czechia, 500 05
- Research Site
-
Liberec, Czechia, 460 63
- Research Site
-
Olomouc, Czechia, 775 20
- Research Site
-
Plzen, Czechia, 305 99
- Research Site
-
Praha 4, Czechia, 140 21
- Research Site
-
Praha 5, Czechia, 150 06
- Research Site
-
Usti nad Labem, Czechia, 401 13
- Research Site
-
Zlin, Czechia, 762 75
- Research Site
-
-
-
-
-
Aachen, Germany, 52074
- Research Site
-
Bad Reichenhall, Germany, 83435
- Research Site
-
Berlin, Germany, 12627
- Research Site
-
Berlin, Germany, 13353
- Research Site
-
Bielefeld, Germany, 33602
- Research Site
-
Bochum, Germany, 44787
- Research Site
-
Borsdorf, Germany, 04451
- Research Site
-
Detmold, Germany, 32756
- Research Site
-
Garbsen, Germany, 30823
- Research Site
-
Germering, Germany, 82110
- Research Site
-
Göttingen, Germany, 37075
- Research Site
-
Halberstadt, Germany, 38820
- Research Site
-
Halle (Saale), Germany, 06120
- Research Site
-
Hamburg, Germany, 20095
- Research Site
-
Langenhagen, Germany, 30851
- Research Site
-
Leipzig, Germany, 04317
- Research Site
-
Mainz, Germany, 55131
- Research Site
-
Mannheim, Germany, 68165
- Research Site
-
Markleeberg, Germany, 04416
- Research Site
-
Muenchen, Germany, 80331
- Research Site
-
Mönchengladbach, Germany, 41063
- Research Site
-
Mühldorf, Germany, 84453
- Research Site
-
Mülheim an der Ruhr, Germany, 45468
- Research Site
-
München, Germany, 80331
- Research Site
-
München, Germany, 80638
- Research Site
-
Neuwied, Germany, 56564
- Research Site
-
Nürnberg, Germany, 90443
- Research Site
-
Oschatz, Germany, 04758
- Research Site
-
Pirna, Germany, 01796
- Research Site
-
Potsdam, Germany, 14471
- Research Site
-
Rostock, Germany, 18059
- Research Site
-
Rotenburg, Germany, 27356
- Research Site
-
Viersen-Dülken, Germany, 41751
- Research Site
-
Villingen-Schwenningen, Germany, 78052
- Research Site
-
Zwickau, Germany, 08060
- Research Site
-
-
-
-
-
Alexandroupoli, Greece, 68100
- Research Site
-
Athens, Greece, 11527
- Research Site
-
Athens, Greece, 16673
- Research Site
-
Athens, Greece, 12462
- Research Site
-
Athens, Greece, 14233
- Research Site
-
Athens, Greece, 10676
- Research Site
-
Athens, Greece, 11521
- Research Site
-
Athens, Greece, 11526
- Research Site
-
Athens, Greece, 14561
- Research Site
-
Athens, Greece, 17674
- Research Site
-
Heraklion, Greece, 71110
- Research Site
-
Ioannina, Greece, 45500
- Research Site
-
Larissa, Greece, 41110
- Research Site
-
Piraeus, Greece, 18536
- Research Site
-
Thessaloniki, Greece, 54636
- Research Site
-
Thessaloniki, Greece, 56429
- Research Site
-
Thessaloniki, Greece, 56403
- Research Site
-
-
-
-
-
Acerra, Italy
- Research Site
-
Arzignano, Italy, 36071
- Research Site
-
Asti, Italy, 14100
- Research Site
-
Bassano Del Grappa (VI), Italy, 36061
- Research Site
-
Bologna, Italy, 40133
- Research Site
-
Brescia, Italy, 25123
- Research Site
-
Brindisi, Italy, 72100
- Research Site
-
Catanzaro, Italy, 88100
- Research Site
-
Cinisello Balsamo (MI), Italy, 20092
- Research Site
-
Cona FE, Italy, 44124
- Research Site
-
Cosenza, Italy, 87100
- Research Site
-
Foggia, Italy, 71100
- Research Site
-
Lido Di Camaiore LU, Italy, 55041
- Research Site
-
Messina, Italy, 89125
- Research Site
-
Mestre (VE), Italy, 30174
- Research Site
-
Milano, Italy, 20132
- Research Site
-
Milano, Italy, 20138
- Research Site
-
Milano, Italy, 20142
- Research Site
-
Napoli, Italy, 80131
- Research Site
-
Padova, Italy, 35128
- Research Site
-
Palermo, Italy, 90127
- Research Site
-
Pescara, Italy, 65100
- Research Site
-
Reggio Calabria, Italy, 89124
- Research Site
-
Rivoli, Italy, 10098
- Research Site
-
Roma, Italy, 00168
- Research Site
-
Roma, Italy, 00161
- Research Site
-
Salerno, Italy, 84131
- Research Site
-
Seriate, Italy, 24068
- Research Site
-
Sesto San Giovanni (MI), Italy, 20099
- Research Site
-
Taranto, Italy, 74100
- Research Site
-
Torrette Di Ancona, Italy, 60126
- Research Site
-
Treviglio (BG), Italy, 24047
- Research Site
-
Trieste, Italy, 34125
- Research Site
-
-
-
-
-
Almada, Portugal, 2801-951
- Research Site
-
Carnaxide, Portugal, 2790-134
- Research Site
-
Coimbra, Portugal, 3000-075
- Research Site
-
Faro, Portugal, 8000-386
- Research Site
-
Matosinhos, Portugal, 4464-513
- Research Site
-
Porto, Portugal, 4099-001
- Research Site
-
-
-
-
-
Banska Bystrica, Slovakia, 974 01
- Research Site
-
Bratislava, Slovakia, 826 06
- Research Site
-
Bratislava, Slovakia, 833 48
- Research Site
-
Bratislava, Slovakia, 831 01
- Research Site
-
Bratislava, Slovakia, 813 69
- Research Site
-
Bratislava, Slovakia, 831 06
- Research Site
-
Brezno, Slovakia, 977 42
- Research Site
-
Handlova, Slovakia, 972 51
- Research Site
-
Komarno, Slovakia, 945 01
- Research Site
-
Kosice, Slovakia, 040 01
- Research Site
-
Kosice, Slovakia, 040 22
- Research Site
-
Martin, Slovakia, 036 01
- Research Site
-
Martin, Slovakia, 036 59
- Research Site
-
Moldava nad Bodvou, Slovakia, 045 01
- Research Site
-
Myjava, Slovakia, 907 01
- Research Site
-
Namestovo, Slovakia, 029 01
- Research Site
-
Nitra, Slovakia, 949 01
- Research Site
-
Nitra, Slovakia, 950 01
- Research Site
-
Nitra, Slovakia, 949 88
- Research Site
-
Nove Mesto nad Vahom, Slovakia, 915 01
- Research Site
-
Nove Zamky, Slovakia, 940 01
- Research Site
-
Poprad, Slovakia, 058 01
- Research Site
-
Presov, Slovakia, 080 01
- Research Site
-
Roznava, Slovakia, 048 01
- Research Site
-
Trnava, Slovakia, 917 01
- Research Site
-
Zilina, Slovakia, 010 01
- Research Site
-
-
-
-
-
Madrid, Spain, 28046
- Research Site
-
Madrid, Spain, 28041
- Research Site
-
Madrid, Spain, 28006
- Research Site
-
-
Andalucía
-
Cadiz, Andalucía, Spain, 11009
- Research Site
-
Huelva, Andalucía, Spain, 21080
- Research Site
-
Jaen, Andalucía, Spain, 23007
- Research Site
-
Malaga, Andalucía, Spain, 29010
- Research Site
-
Sevilla, Andalucía, Spain, 41013
- Research Site
-
Sevilla, Andalucía, Spain, 41009
- Research Site
-
-
Baleares
-
Palma de Mallorca, Baleares, Spain, 07010
- Research Site
-
-
Cataluña
-
Badalona, Cataluña, Spain, 08916
- Research Site
-
Barcelona, Cataluña, Spain, 08041
- Research Site
-
Reus, Cataluña, Spain, 43204
- Research Site
-
Sabadell, Cataluña, Spain, 08208
- Research Site
-
-
Galicia
-
Ferrol, Galicia, Spain, 15405
- Research Site
-
Lugo, Galicia, Spain, 27003
- Research Site
-
-
Madrid
-
Alcala de Henares, Madrid, Spain, 28805
- Research Site
-
-
-
-
-
Göteborg, Sweden, 413 45
- Research Site
-
Malmo, Sweden, 205 02
- Research Site
-
Stockholm, Sweden, 141 86
- Research Site
-
Uppsala, Sweden, 751 85
- Research Site
-
-
-
-
-
Basel, Switzerland, 4031
- Research Site
-
Geneva 14, Switzerland, 1211
- Research Site
-
Lugano, Switzerland, 6900
- Research Site
-
Winterthur, Switzerland, 8401
- Research Site
-
Zurich, Switzerland, 8063
- Research Site
-
Zurich, Switzerland, 8091
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
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®
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Group 1
To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of clinical characteristics of subjects initiated on Repatha®
Time Frame: Study day 1
|
Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance
|
Study day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe LDL-C and other cholesterol values over time
Time Frame: Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha®
|
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®
|
|
Describe Repatha® dose over time
Time Frame: From the first dose of Repatha® up to 30 months post first dose
|
Record Repatha® dose in mg
|
From the first dose of Repatha® up to 30 months post first dose
|
|
Describe use of other lipid-modifying therapies
Time Frame: From the first dose of Repatha® up to 30 months post first dose
|
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
|
|
Describe Physician visits
Time Frame: From the first dose of Repatha® up to 30 months post first dose
|
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
|
|
Describe hospitalizations
Time Frame: From the first dose of Repatha® up to 30 months post first dose
|
Detail all hospitalizations from enrolment to end of study
|
From the first dose of Repatha® up to 30 months post first dose
|
|
Describe Repatha® dose frequency over time
Time Frame: From the first dose of Repatha® up to 30 months post first dose
|
Record dose frequency (Q2W, QM)
|
From the first dose of Repatha® up to 30 months post first dose
|
|
Describe Repatha® administrative device use over time
Time Frame: From the first dose of Repatha® up to 30 months post first dose
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2016
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
April 27, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimated)
May 12, 2016
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
June 4, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20130296
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolaemia
-
Daiichi SankyoActive, not recruitingMixed Dyslipidemia | Primary HypercholesterolaemiaBrazil
-
AstraZenecaNot yet recruiting
-
AstraZenecaNot yet recruiting
-
Humanis Saglık Anonim SirketiCompleted
-
Federico II UniversityRecruitingHypercholesterolaemiaItaly
-
Moon (Guangzhou) Biotechnology Co., Ltd.RecruitingHypercholesterolaemiaChina
-
AkesoAD Pharmaceuticals Co., Ltd.Completed
-
GlaxoSmithKlineCompleted
-
AstraZenecaCompletedHypercholesterolaemiaBosnia and Herzegovina
-
AstraZenecaCompleted