Improving cholesterol treatment for blood donors with high cholesterol
Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
This study is testing a new way to help blood donors with high cholesterol manage their condition better than the usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05693701 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance cholesterol management among blood donors diagnosed with Familial Hypercholesterolemia (FH). It is a single-center, randomized trial comparing usual care with an implementation bundle intervention. Participants will undergo screening, receive follow-up calls, and complete virtual visits to assess their cholesterol levels and any adverse events. The study will involve blood and urine sample collection for eligibility and LDL-C measurement.
Who should consider this trial
Good fit: Ideal candidates are blood donors aged 18 to 75 with high cholesterol who meet the MEDPED FH criteria.
Not a fit: Patients currently taking cholesterol-lowering medications or those with certain medical conditions like chronic liver disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cholesterol treatment strategies for blood donors, potentially reducing cardiovascular risks.
How similar studies have performed: Other studies have shown success in improving cholesterol management through targeted interventions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Amit Khera, MD — University of Texas Southwestern Medical Center
- Study coordinator: Amit Khera, MD
- Email: Amit.Khera@UTSouthwestern.edu
- Phone: 214.645.7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.