Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

NCT03110432 | Completed

• 1 other identifier: PERI-DYS
• Study Type: observational
• Target: 1,695
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.

Conditions

Dyslipoproteinemias; Hypercholesterolemia, Familial; Familial Hypercholesterolemia - Homozygous; Familial Combined Hyperlipidemia

Keywords

Cardiovascular; LDL Cholesterol; Drug utlisation; high risk; secondary prevention; PCSK9 inhibition

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol goal achievement

  \< 70 mg/dl

  3 years

Secondary Outcomes (2)

• LDL cholesterol reduction

  up top 3 years

• Number of treatment changes

  up to 3 years

Other Outcomes (1)

• Change in quality of life

  up to 3 years

Study Arms (2)

Standard lipid lowering therapy

Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents)

Drug: Standard lipid lowering therapy

PCSK9 Inhibitor [EPC]

Evolocumab or alirocumab.

Drug: PCSK9 Inhibitor [EPC]

Interventions

PCSK9 Inhibitor [EPC] DRUG

drug use according to the respective product labelling

Also known as: Repatha, Praluent

PCSK9 Inhibitor [EPC]

Standard lipid lowering therapy DRUG

drug use according to the respective product labelling

Also known as: Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids

Standard lipid lowering therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dyslipidemia and very high cardiovascular risk ("highest risk patients" according to G-BA stipulation for PCSK9i use)

You may qualify if:

• with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or
• with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or
• with heterozygous familial or non- familial hypercholesterolemia or mixed dyslipidemia with
• therapy refractory course
• maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period
• unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis)
• confirmed vascular disease
• other risk factors for cardiovascular events

You may not qualify if:

• Concurrent participation of the patient in a clinical randomised study.

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (3)

Klinik und Poliklinik für Kardiologie, Universitätsklinikum

Leipzig, Germany

Location

Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum

Tübingen, Germany

Location

Nephrologisches Zentrum

Villingen-Schwenningen, Germany

Location

Related Publications (3)

• Parhofer KG, Pittrow D, Birkenfeld AL, Fraass U, Hohenstein B, Siegert C, Klotsche J, Steinhagen-Thiessen E, Dexl S, Schettler VJJ, Laufs U. Determinants of lipid lowering therapy intensification in very high risk patients with dyslipidaemia eligible for PCSK9 monoclonal antibodies: 1-year outcomes of the PERI-DYS study. Acta Cardiol. 2025 Jul;80(5):475-486. doi: 10.1080/00015385.2025.2490381. Epub 2025 Apr 24.

  PMID: 40270128 BACKGROUND

• Laufs U, Birkenfeld AL, Fraass U, Hohenstein B, Siegert C, Klotsche J, Steinhagen-Thiessen E, Pittrow D, Dexl S, Salmen S, Schettler VJJ, Parhofer KG; Collaborators in the PERI-DYS Study. Novel Insights into the Management of Patients with Very High Cardiovascular Risk Eligible for PCSK9 Inhibitor Treatment: Baseline Findings from the PERI-DYS Study. Cardiovasc Drugs Ther. 2024 Feb;38(1):119-129. doi: 10.1007/s10557-022-07386-0. Epub 2022 Sep 30.

  PMID: 36178485 BACKGROUND

• Parhofer KG, Pittrow D, Birkenfeld AL, Fraass U, Hohenstein B, Siegert C, Klotsche J, Steinhagen-Thiessen E, Dexl S, Schettler VJJ, Laufs U. Treatment persistence, lipid lowering, and 3-year clinical outcomes in patients at very high cardiovascular risk on PCSK9 monoclonal antibodies. Clin Res Cardiol. 2026 Feb;115(2):288-303. doi: 10.1007/s00392-025-02719-z. Epub 2025 Aug 4.

  PMID: 40760109 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hyperlipidemia, Familial Combined

Interventions

erucylphosphocholine; evolocumab; alirocumab; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ezetimibe; Niacin; Fibric Acids; Colesevelam Hydrochloride; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Allylamine; Amines; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• David Pittrow, MD, PhD

  GWT-TUD GmbH, Germany

  PRINCIPAL INVESTIGATOR

• Andreas Birkenfeld, MD, PhD

  Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum Tuebingen, Germany

  STUDY CHAIR

• Bernd Hohenstein, MD, PhD

  Nephrologisches Zentrum Villingen-Schwenningen, Germany

  STUDY CHAIR

• Ulrich Laufs, MD, PhD

  Klinik für Innere Medizin III, Universität des Saarlandes, Germany

  STUDY CHAIR

• Volker JJ Schettler, MD, PhD

  Nephrologisches Zentrum Göttingen GbR, Germany

  STUDY CHAIR

• Elisabeth Steinhagen-Thiessen, MD, PhD

  Lipid Clinic, Charité Universitaetsmedizin, Berlin, Germany

  STUDY CHAIR

• Klaus G Parhofer, MD, PhD

  Ludwig Maximilian University, Medizinische Klinik und Poliklinik IV, Muenchen, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 12, 2017
• Study Start: May 18, 2017
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)