NCT05238519CompletedPhase 3
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational interview. Primary study outcomes include knowledge of FH, as well as clinical and patient-reported outcomes. This study aims to promote optimal disease management and improve outcomes of FH patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 257 (actual)
- First submitted
- 3 Feb 2022
- Start date
- 15 Feb 2022
- Primary completion date
- 6 Nov 2024
- Lead sponsor
- Essentia Health
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05238519
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 257
- From 15 Feb 2022 to the primary completion date, 6 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism)
Other
- Lack of research authorization
- unable to provide informed consent (including non-English speaking individuals)
- Pregnant women and prisoners will also be excluded.
Who the study is looking for
- Age 2-75 years
- patients with existing clinical diagnosis or suspected FH
- known genetic mutation of FH
- patients with an initial (pretreatment) LDL level \>190 mg/dL or total cholesterol \>300 mg/dL (age \>19 years) or LDL-c \> 160mg/dL or total cholesterol \>260 mg/dL in children age 2-19 years
- patients currently taking a lipid-lowering medication and have an LDL \>124 mg/dL or total cholesterol \>195 mg/dL
- capable of providing informed consent
- Patients should reside in Minnesota, Wisconsin or North Dakota.
Age in the registry: 2 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Essentia Health Coordinator of this site? Confirm its status | Duluth | United States | Unknown status |
| Aspirus St. Luke's Hospital Coordinator of this site? Confirm its status | Duluth | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.