DyslipoproteinemiasPERI-DYSNCT03110432
Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry
An observational study of Dyslipoproteinemias and Hypercholesterolemia, Familial, run by GWT-TUD GmbH at 3 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dyslipoproteinemias, Hypercholesterolemia, Familial, Familial Hypercholesterolemia - Homozygous
- What is being tested?
- PCSK9 Inhibitor [EPC] and Standard lipid lowering therapy
- How many people
- 1,695 participants
- Where
- 3 sitesGermany
- Study dates
- 18 May 2017to 17 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dyslipidemia and very high cardiovascular risk ("highest risk patients" according to G-BA stipulation for PCSK9i use)
Who may be able to join
- • 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
Who cannot join
- Concurrent participation of the patient in a clinical randomised study.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinik und Poliklinik für Kardiologie, Universitätsklinikum
Leipzig
Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum
Tübingen
Nephrologisches Zentrum
Villingen-Schwenningen
About this study
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.
Read the detailed 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.
- Conditions
- Dyslipoproteinemias, Hypercholesterolemia, Familial, Familial Hypercholesterolemia - Homozygous, Familial Combined Hyperlipidemia
- Being tested
- PCSK9 Inhibitor [EPC], Standard lipid lowering therapy
- Keywords
- Cardiovascular, LDL Cholesterol, Drug utlisation, high risk, secondary prevention, PCSK9 inhibition
- Medical subject headings
- Dyslipidemias, Hyperlipoproteinemia Type II, Homozygous Familial Hypercholesterolemia, Hyperlipidemia, Familial Combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 Inhibitor [EPC]Drug
Also called Repatha, Praluent
drug use according to the respective product labelling
Standard lipid lowering therapyDrug
Also called Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids
drug use according to the respective product labelling
| Study group | Role | What they receive |
|---|---|---|
| Standard lipid lowering therapy | Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents) Receives: Drug: Standard lipid lowering therapy | |
| PCSK9 Inhibitor [EPC] | Evolocumab or alirocumab. Receives: Drug: PCSK9 Inhibitor [EPC] |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol goal achievement
< 70 mg/dl
Measured: 3 years
Secondary outcomes (2)
LDL cholesterol reduction
Compared to baseline
Measured: up top 3 years
Number of treatment changes
During the follow-up period
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start18 May 2017
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipoproteinemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Pittrow, MD, PhD, Principal investigator, GWT-TUD GmbH, GermanyAndreas Birkenfeld, MD, PhD, Study chair, Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum Tuebingen, GermanyBernd Hohenstein, MD, PhD, Study chair, Nephrologisches Zentrum Villingen-Schwenningen, GermanyUlrich Laufs, MD, PhD, Study chair, Klinik für Innere Medizin III, Universität des Saarlandes, GermanyVolker JJ Schettler, MD, PhD, Study chair, Nephrologisches Zentrum Göttingen GbR, GermanyElisabeth Steinhagen-Thiessen, MD, PhD, Study chair, Lipid Clinic, Charité Universitaetsmedizin, Berlin, GermanyKlaus G Parhofer, MD, PhD, Study chair, Ludwig Maximilian University, Medizinische Klinik und Poliklinik IV, Muenchen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110432
- Sponsor's protocol ID
- PERI-DYS
- Acronym
- PERI-DYS
- Status last verified
- May 2025
- First submitted
- 31 Mar 2017
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40270128Laufs 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.
PubMed 36178485Parhofer 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.
PubMed 40760109
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry
- ClinicalTrials.gov ID
- NCT03110432
- Acronym / sponsor ID
- PERI-DYS / PERI-DYS
- Conditions
- Dyslipoproteinemias, Hypercholesterolemia, Familial, Familial Hypercholesterolemia - Homozygous, Familial Combined Hyperlipidemia
- Keywords
- Cardiovascular, LDL Cholesterol, Drug utlisation, high risk, secondary prevention, PCSK9 inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,695 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard lipid lowering therapy | – | Drug: Standard lipid lowering therapyStatins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids (and any combinations of these agents) |
| PCSK9 Inhibitor [EPC] | – | Drug: PCSK9 Inhibitor [EPC]Evolocumab or alirocumab. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dyslipidemia and very high cardiovascular risk ("highest risk patients" according to G-BA stipulation for PCSK9i use)
Key inclusion criteria (8 listed)
- • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or
Key exclusion criteria (1 listed)
- Concurrent participation of the patient in a clinical randomised study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCSK9 Inhibitor [EPC]Also: Repatha, Praluentdrug use according to the respective product labelling | Drug | PCSK9 Inhibitor [EPC] |
| Standard lipid lowering therapyAlso: Statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acidsdrug use according to the respective product labelling | Drug | Standard lipid lowering therapy |
Primary outcome
LDL cholesterol goal achievement
Time frame: 3 years
< 70 mg/dl
2 secondary outcomes
LDL cholesterol reduction
Time frame: up top 3 years
Number of treatment changes
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Results publication: PubMed 40270128Parhofer 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.
- Results publication: PubMed 36178485Laufs 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.
- Derived from this study: PubMed 40760109Parhofer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pittrow, MD, PhD principal investigator
GWT-TUD GmbH, Germany
Andreas Birkenfeld, MD, PhD study chair
Innere Medizin IV - Diabetologie, Endokrinologie und Nephrologie am Universitaetsklinikum Tuebingen, Germany
Bernd Hohenstein, MD, PhD study chair
Nephrologisches Zentrum Villingen-Schwenningen, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipoproteinemias and Hypercholesterolemia, Familial, run by GWT-TUD GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol goal achievement (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03110432, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.