NCT05693701

Brief Summary

The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Feb 2023Apr 2027

First Submitted

Initial submission to the registry

January 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

January 11, 2023

Last Update Submit

March 13, 2026

Conditions

Lipid Metabolism Disorder

Keywords

Blood DonorsHigh CholesterolLDL Cholesterol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Difference in 6 month LDL-C values between the two treatment arms

    6 months

  • Proportion of participants prescribed high-intensity statin therapy

    6 months

  • Proportion of participants prescribed any statin therapy

    6 months

  • Difference in participants' knowledge regarding FH at the end of study

    6 months

Study Arms (2)

Control group (Usual care)

OTHER

This arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol

Other: Usual care notification

Intervention Group (Implementation strategy bundle)

EXPERIMENTAL

Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)

Behavioral: Implementation Strategy BundleOther: Usual care notification

Interventions

Usual care notificationOTHER

Carter BloodCare will notify participants of their high cholesterol, potential for genetic causes, and recommendation to see their care provider by sending its routine, standard notification letter. These participants will also be eligible to receive the intervention bundle at the end of the study.

Control group (Usual care)Intervention Group (Implementation strategy bundle)
Implementation Strategy BundleBEHAVIORAL

Bundle includes multimodal communications to notify donors about high cholesterol and its treatment, website with resources, and an optional care navigator. Resources for their primary care provider will also be disseminated.

Intervention Group (Implementation strategy bundle)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria
  • Age 18 to 75 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Lipid Metabolism DisordersHypercholesterolemia

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemiasDyslipidemias

Study Officials

  • Amit Khera, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Khera, MD

CONTACT

214.645.7500Amit.Khera@UTSouthwestern.edu

Lakeisha Cade

CONTACT

214.648.2878Lakeisha.Cade@UTSouthwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Treatment assignment will be via block randomization stratified on age category in a 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR - Internal Medicine

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 23, 2023

Study Start

February 27, 2023

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)