Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

Dyslipoproteinemias Clinical Trial

— PERI-DYS  

Official title:

Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03110432
• Other study ID #: PERI-DYS
• Status: Active, not recruiting
• Start date: May 18, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study is purely observational, and will document data from the patient charts only. Treatment of patients will not be changed by this study, and all clinical decisions (including on frequency of visits) will be upon the discretion of the physician. No blood samples must be taken solely for the purpose of the study.

The registry will include two types of centers: 1) office-based cardiologists and 2) specialized lipid ambulances (outpatient departments).

Data on patient disease and treatment history will be collected a first documentation (retrospectively).

The documentation time is 3 years per patient. After the baseline visit, patients are followed-up every 6 ± 2months (last visit at month 36). This interval is considered narrow enough not to miss important events (safety reporting, cardiovascular events, hospitalizations).

Patients with stable (maintenance) lipid-lowering therapy (including those with existing PCSK9i therapy) or those with any therapy changes (including newly initiated PCSK9i treatment) will be documented in this study. Compared to the former group with stable drug treatment, the latter group will likely have major LDL-C changes during the first few weeks, which will be accounted for by (retrospective) monthly documentation in the first 3 months (data will be documented at the 6-month visit.

The documentation periods will be substantially longer than in the controlled studies of the PCSK9i (endpoints were as early as 3 months), and thus will provide much-needed information about the long-term effects on LDL-C and other lipid parameters, safety, and drug retention rates. Longer follow-up periods would likely be compromised by high rates of (administrative) discontinuation rates.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1713
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• • 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dyslipidemias
• Dyslipoproteinemias

Intervention

Drug:
• PCSK9 Inhibitor [EPC]
drug use according to the respective product labelling
• Standard lipid lowering therapy
drug use according to the respective product labelling

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Kardiologie, Universitätsklinikum	Leipzig
Germany	Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum	Tübingen
Germany	Nephrologisches Zentrum	Villingen-Schwenningen

Sponsors (1)

Lead Sponsor	Collaborator
GWT-TUD GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Cardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life	by EuroQol 5 dimensions	up to 3 years
Primary	LDL cholesterol goal achievement	< 70 mg/dl	3 years
Secondary	LDL cholesterol reduction	Compared to baseline	up top 3 years
Secondary	Number of treatment changes	During the follow-up period	up to 3 years