Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT05988866
Eligibility Criteria:
Inclusion criteria
* Age ≥ 18
* Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis
* LDL-C levels above risk-adapted target
* TG levels \< 400 mg/dL
* Stability of potential drug treatment during the last 4 weeks
* Stability of potential hormonal treatment during the last 6 months
* Patient was made aware of lifestyle measures by GP or specialist
* Consent to participation
* Sufficient knowledge of the German language
Exclusion criteria
* Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
* Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
* Patients receiving plasmapheresis
* Lp(a) \> 50 mg/dL
* current pregnancy or planned pregnancy during the study period
* planned major operations
* liver dysfunction
* end-stage renal failure
* other systemic conditions that might interfere with successful study participation
* Plans to change drug (including hormonal) treatment in the upcoming 6 months
* Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05988866
Study Brief:
Protocol Section:
NCT05988866