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New program aims to lower cholesterol in blood donors with genetic condition

NCT ID NCT05693701

Disease control Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a program to help blood donors who have familial hypercholesterolemia (a genetic condition causing very high cholesterol) get proper treatment. One hundred participants will either receive standard notification about their condition or a bundle of extra support, including educational materials and a care navigator. The goal is to see if the extra support leads to lower LDL cholesterol levels after six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implementation Strategy Bundle (behavioral intervention)
What this could lead to
If successful, this could provide a practical way to help people with inherited high cholesterol get their levels under control and reduce heart disease risk.
What could go wrong
This is a small, early-stage study focused on implementation, not a new drug. Results may not apply to everyone, and the intervention may not lead to lasting cholesterol improvements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia Hypercholesterolemia inherited lipid metabolism disorder Lipid Metabolism Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lipid metabolism disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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