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Study of Awareness and Detection of Familial Hypercholesterolemia (CASCADE-FH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01960244
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : April 26, 2022
Information provided by (Responsible Party):
The Familial Hypercholesterolemia Foundation

Brief Summary:
The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy, clinical outcomes, and patient-reported outcomes over time. The registry represents a collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical Research Institute, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes.

Condition or disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: CASCADE FH Registry (CAscade SCreening for Awareness and DEtection of Familial Hypercholesterolemia Registry)
Study Start Date : October 2013
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

familial hypercholesterolemia

Primary Outcome Measures :
  1. Promote awareness of FH to increase the number of identified FH patients, reaching optimal level of disease management; target treatment levels for LDL cholesterol. [ Time Frame: 3 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed Familial hypercholesterolemia (FH).

Inclusion Criteria:

Online Patient Enrollment Inclusion Criteria:

  • Patients with existing clinical diagnosis of FH;
  • Patients with genetic mutation of FH;
  • Patients with an initial (pretreatment) LDL level >190 mg/dL or total cholesterol >300 mg/dL;
  • Patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL.

Clinic Patient Enrollment Inclusion Criteria:

  • Patients with existing clinical diagnosis of FH using one of the three clinical diagnostic (US MedPed Program Criteria, Simon Broome Register Criteria with diagnosis of "Probable", Dutch Lipid Clinic Network Diagnostic Criteria with diagnosis of "Probable")tools for FH; or
  • Patients with genetic mutation of FH

Exclusion Criteria:

  • Patients will be excluded from participation in the registry when a known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960244

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Contact: MARY CARD, MBA 6265834674 mcc@thefhfoundation.org

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United States, California
Stanford Center for Inherited Cardiovascular Diseases Recruiting
Palo Alto, California, United States, 94304
Contact: Hannah Ison    650-575-9589    hison@stanfordhealthcare.org   
Principal Investigator: Joshua Knowles, MD         
Sponsors and Collaborators
The Familial Hypercholesterolemia Foundation
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Study Director: Katherine Wilemon FHFoundation
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Familial Hypercholesterolemia Foundation
ClinicalTrials.gov Identifier: NCT01960244    
Other Study ID Numbers: Pro00045568
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: October 2021
Keywords provided by The Familial Hypercholesterolemia Foundation:
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn