Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Running, not enrolling · Phase 3
Conditions studied: Familial Hypercholesterolemia, Cholesterol, Elevated, Genetic Disease
In brief
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.
Key facts
- Study ID
- NCT05238519
- Run by
- Essentia Health
- People needed
- 300
- Starts
- 2022-02-15
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 2 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Lack of research authorization
- unable to provide informed consent (including non-English speaking individuals)
- known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism)
- Pregnant women and prisoners will also be excluded.
Where it is running
- Aspirus St. Luke's Hospital — Duluth, Minnesota, United States
- Essentia Health — Duluth, Minnesota, United States
Full record on ClinicalTrials.gov
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