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Search / Trial NCT05238519

Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)

Launched by ESSENTIA HEALTH · Feb 3, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cholesterol Motivational Interview Survey Cascade Screening

ClinConnect Summary

The Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH) study is focused on raising awareness and improving the management of Familial Hypercholesterolemia (FH), a genetic condition that causes high cholesterol levels. The trial is looking for patients aged 2 to 75 who have either been diagnosed with FH or are suspected of having it. Participants will be randomly assigned to receive either standard medical care or a special motivational interview designed to help them understand their condition better. By measuring how much patients know about FH and tracking their health outcomes, the study aims to find ways to improve the care and support for people living with this condition.

To be eligible for the trial, participants should live in Minnesota, Wisconsin, or North Dakota and have specific cholesterol levels that indicate a risk for FH. This includes adults with an LDL (bad cholesterol) level over 190 mg/dL or children with elevated cholesterol levels. The study will not include individuals who cannot give consent, are pregnant, or have other medical conditions that might affect their cholesterol levels. If you join the study, you’ll gain valuable information about FH and how to manage it, while also contributing to research that may help others in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Essentia Health

Essentia Health is a comprehensive healthcare organization dedicated to improving patient outcomes through innovative research and clinical trials. With a commitment to advancing medical knowledge and enhancing treatment options, Essentia Health collaborates with various stakeholders, including academic institutions and industry partners, to conduct rigorous studies across a range of therapeutic areas. The organization emphasizes patient-centered care and ethical research practices, ensuring that participants receive the highest standard of support and safety throughout their involvement in clinical trials. Through these efforts, Essentia Health aims to contribute to the development of effective therapies and improve the overall health of the communities it serves.

Locations

Duluth, Minnesota, United States

Duluth, Minnesota, United States

Duluth, Minnesota, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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