German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

NCT05438069 | Unknown

• 1 other identifier: 2021-2429
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• LDL-C change

  LDL-C change in mg/dL / mmol/L

  3 months, 6 months, 12 months, 24 months

Study Arms (1)

Patients with elevated LDL-cholesterol (hypercholesterolemia)

Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

-patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran

You may qualify if:

• patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
• patients 18 years and older

You may not qualify if:

• \- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.

Sponsors & Collaborators

• Jena University Hospital: lead
• Universitätsklinikum Leipzig: collaborator
• Charite University, Berlin, Germany: collaborator
• Technische Universität Dresden: collaborator
• Deutsches Herzzentrum Muenchen: collaborator
• University of Rostock: collaborator
• Ruhr University of Bochum: collaborator
• Universitätsmedizin Mannheim: collaborator
• LMU Klinikum: collaborator

Study Sites (1)

Jena University Hospital

Jena, Germany

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Oliver Weingaertner, MD

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Weingaertner, MD

CONTACT

+4936419324521; oliver.weingaertner@med.uni-jena.de

Martin Foerster, PhD

CONTACT

+4936419325818; martin.foerster@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: December 11, 2020
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3 months after publication for 3 years
• Access Criteria: Data that will be shared: Study protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.

Locations

DE (1)