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Which contact method best warns families of hidden cholesterol danger?

NCT ID NCT07653555

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study compares two approaches to notify relatives of people diagnosed with familial hypercholesterolemia (FH), a genetic condition causing very high cholesterol. One method lets patients share information themselves; the other has the study team contact relatives directly. Researchers will track how many family members get tested for FH within a year to see which approach works better.

What this could mean

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

Active substance
cascade testing (direct vs. indirect contact methods)
What this could lead to
If one method works better, it could help more families learn about their inherited risk for high cholesterol and take early action.
What could go wrong
This is a small, early-stage study focused on testing methods, not a treatment. Results may not apply to all populations or healthcare settings.

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 480 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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

1 year and older

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: Index Patients: * Age ≥ 18 years. * Confirmed FH diagnosis using Dutch Lipid Clinic Network criteria \*or\* genetic confirmation. * Identified through REP or Tapestry databases. * Able and willing to provide informed consent. * At least one eligible first- or second-degree relative. * Access to and active use of email (computer literacy requirement). Relatives: * First- or second-degree relative of an enrolled index patient. * Age ≥ 1 year (minors require parental consent + assent). * Willing to participate and able to complete electronic consent (guardian-assisted if minor). * Access to and active use of email (guardian). Exclusion Criteria: Index Patients: * No confirmed FH diagnosis. * Insufficient clinical follow-up (\<5 years). * No identifiable or contactable relatives. * Prior participation in structured cascade testing. * Severe cognitive impairment preventing informed consent. Relatives: * Prior participation in structured cascade testing. * Severe cognitive impairment preventing informed consent.

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia Hyperlipoproteinemia Type II

As listed by the trial registrant

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

Familial hypercholesterolemia

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.