Lipid Metabolism Disorder Clinical Trial
— DONATE-FHOfficial title:
Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 28, 2027 |
Est. primary completion date | February 28, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria - Age 18 to 75 years Exclusion Criteria: - Currently taking medication to lower cholesterol - Taking any medication that can interact with statins - Pregnancy - Identified secondary cause of elevated lipids - Chronic liver disease or significantly elevated liver function tests (> 3 times upper limit) |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in change in LDL cholesterol levels from baseline to 6 months | This is the difference between the two study arms in change in LDL cholesterol level measurements obtained from lab work of blood samples from baseline and at 6 months | Baseline, 6 months | |
Secondary | Difference in 6 month LDL-C values between the two treatment arms | This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples. | 6 months | |
Secondary | Proportion of participants prescribed high-intensity statin therapy | Proportion of participants prescribed high-intensity statin therapy will be calculated as the number of patients who were prescribed high-intensity statin therapy in each arm divided by the total number of participants analyzed in each arm | 6 months | |
Secondary | Proportion of participants prescribed any statin therapy | Proportion of participants prescribed any statin therapy will be calculated as the number of patients who were prescribed any statin therapy in each arm divided by the total number of participants analyzed in each arm | 6 months | |
Secondary | Difference in participants' knowledge regarding FH at the end of study | Difference in participant's knowledge regarding FH at 6 months is measured using a validated FH knowledge survey where higher scores indicate greater knowledge. Comparisons between the two study arms will be made. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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