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Heart study volunteers get their genetic secrets back

NCT ID NCT04196374

Knowledge-focused Sponsor: Brigham and Women's Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 3 times

Summary

This study looked at how to return important genetic findings to people who had already had their genomes sequenced as part of two large heart studies. Researchers contacted 48 participants who had consented to receive results, offering them a chance to confirm and discuss any actionable genetic variants with their doctor. The goal was to understand how many people follow through, what it costs, and whether it leads to better medical care.

What this could mean

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

Active substance
Genomic Sequencing
What this could lead to
If successful, this could help develop efficient, scalable ways to return meaningful genetic results to large populations, potentially improving early detection and prevention of inherited diseases.
What could go wrong
This is a small, completed observational study focused on process and feasibility, not on proving health outcomes. The findings may not apply to other 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

7,603 people

The number who actually took part.

Started

Jun 2021

Finished

May 2025

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 100 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: * Living individuals enrolled in the Framingham Heart Study and the Jackson Heart Study who have had their genomes sequenced as part of the TOPMed program. * Adults over the age of 18 years * Those who have consented to have their DNA samples used for research purposes (and those who participate in gRoR who have consented to receive genomic information). Exclusion Criteria: * Participants of the Framingham Heart Study or Jackson Heart Study who have not had their genomes sequenced as part of TOPMed * Participants who did not opt for genomic/genetic research * Participants who did/do not consent to receiving a genomic result (for the gRoR portion of this study only)

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Conditions

The condition(s) this trial relates to.

inherited disease susceptibility

As listed by the trial registrant

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

Genetic predisposition to disease Seemingly healthy

Contacts and locations

Locations

  • Framingham Heart Study

    Framingham, Massachusetts, 01702, United States

  • Jackson Heart Study

    Jackson, Mississippi, 39213, United States

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