Clinical trial Recruiting at 1 site Observational Ages 18 and up

Collecting skin samples for patients with congenital heart disease

Official title: Clinical Readiness Skin Punch Biopsy Sample Collection

Run by HeartWorks, Inc. · NCT06588426 · Data updated 2026-11-12

This study is collecting skin samples from adults with congenital heart disease to help make it easier to find patients for future treatments.

More Congenital Heart Disease (CHD) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorHeartWorks, Inc.
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedSeptember 13, 2024
Main results expectedJanuary 2027
Study endsJuly 2027
Registry record updatedJune 25, 2025
Trial IDNCT06588426 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older diagnosed with congenital heart disease who may qualify for future clinical trials.

Probably not a fit

Patients who have undergone cardiac transplantation or have certain infectious diseases like HIV or hepatitis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on collecting skin punch biopsy samples from patients with congenital heart disease. The goal is to streamline the process of identifying eligible patients for future interventional treatments, thereby reducing the manufacturing time for necessary products. Participants must be 18 years or older and likely to qualify for an active clinical trial under a specific investigational new drug protocol. The study will not involve any specific interventions at this stage.

Why it matters

Potential benefit: If successful, this study could expedite the treatment process for patients with congenital heart disease by facilitating quicker access to necessary therapies.

How similar studies have gone: While this approach is focused on sample collection, similar studies have shown success in expediting patient eligibility for clinical trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18 and older
* Congenital heart disease
* Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion Criteria:

* Previous cardiac transplantation
* Unable or unwilling to consent
* HIV diagnosis
* Hepatitis diagnosis

Where it's running

  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.