Recruiting

Familial Hypercholesterolemia

Sponsor:

The Familial Hypercholesterolemia Foundation

Code:

NCT01960244

Conditions

Hypercholesterolemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Hypercholesterolemia

Study ID

NCT01960244

Start date

Oct, 2013

Status verified date

Nov, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

hypercholesterolemia

familial hypercholesterolemia

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

MARY CARD, MBA

6265834674mcc@thefhfoundation.org

Locations

Stanford Center for Inherited Cardiovascular Diseases

Recruiting

Palo Alto, California, United States, 94304

Contacts

Hannah Ison

650-575-9589hison@stanfordhealthcare.org

Principal Investigator:

Joshua Knowles, MD

More Information

Sponsor

The Familial Hypercholesterolemia Foundation

Last update posted

Nov 27, 2023

Last verified

Nov, 2023

Keywords

  • familial
  • hypercholesterolemia
  • FH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Familial Hypercholesterolemia Foundation on 2023-11-27.