We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Hypercholesterolemia

  Show Detailed Description

Study Design

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 : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
hypercholesterolemia
familial hypercholesterolemia


Outcome Measures

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 ]
    therapy


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed Familial hypercholesterolemia (FH).
Criteria

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).
Contacts and Locations

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


Locations
United States, North Carolina
Duke Clinical Research Institute Active, not recruiting
Durham, North Carolina, United States, 27705
Duke Clinical Research Institute Recruiting
Durham, North Carolina, United States, 27705
Contact: Shannon Smith-Car    919-668-8785      
Sub-Investigator: Shannon Smith-Car         
Sponsors and Collaborators
The Familial Hypercholesterolemia Foundation
Duke Clinical Research Institute
Investigators
Study Director: Katherine Wilemon FHFoundation
More Information

Additional Information:
Responsible Party: The Familial Hypercholesterolemia Foundation
ClinicalTrials.gov Identifier: NCT01960244     History of Changes
Other Study ID Numbers: Pro00045568
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by The Familial Hypercholesterolemia Foundation:
familial
hypercholesterolemia
FH

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias