Status:
RECRUITING
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Lead Sponsor:
Essentia Health
Collaborating Sponsors:
Aspirus St. Luke's Hospital
WHITESIDE Institute for Clinical Research
Conditions:
Familial Hypercholesterolemia
Cholesterol, Elevated
Eligibility:
All Genders
2-75 years
Phase:
PHASE3
Brief Summary
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 recei...
Detailed Description
This is a randomized 2-arm study designed to examine the impact of a personalized remote intervention that includes evidence-based risk communication and behavior change techniques with navigation. Pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05238519
Start Date
February 15 2022
End Date
December 1 2025
Last Update
February 3 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Aspirus St. Luke's Hospital
Duluth, Minnesota, United States, 55805
2
Essentia Health
Duluth, Minnesota, United States, 55805