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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | HeartWorks, Inc. Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | September 13, 2024 |
| Main results expected | January 2027 |
| Study ends | July 2027 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT06588426 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
- Study coordinator: Adam Armstrong
- Email: clinical@webuildhearts.org
- Phone: (507) 577-1764
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Improving transition of congenital heart disease care from pediatric to adult services
This program will try a multi-step transfer process to reduce health declines in people with congenital heart disease who are waiting to see an adult specialist.
-
HeartGPS: Prenatal mental health support for mothers of babies with CHD
A pregnant person or mother of a baby with congenital heart disease will try a virtual mental health program (HeartGPS) in addition to standard care to see if it helps with well‑being and infant development.
-
Direct breastfeeding to support babies with congenital heart disease and their families
This study tests a breastfeeding-focused program to help infants with CHD breastfeed directly and see how it affects infant health and parental well-being.
-
Music and Multisensory Interventions for Pain During Chest Tube Removal in Infants with Congenital Heart Disease
This trial tests whether music or a multisensory mobile intervention can reduce pain and stabilize physiology during chest tube removal in 2- to 12-month-old infants with congenital heart disease.
-
MedlyPeds: a smartphone app to monitor kids with heart disease
This study tests whether the MedlyPeds app can help kids with heart conditions and their families stay informed and track symptoms remotely.
-
Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts
This project will test whether people with single‑ventricle congenital heart disease who have reduced versus increased pulmonary blood flow do better or worse after the Fontan operation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.