Collecting skin samples for patients with congenital heart disease
Clinical Readiness Skin Punch Biopsy Sample Collection
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HeartWorks, Inc. Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06588426 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with congenital heart disease who may qualify for future clinical trials.
Not a fit: Patients who have undergone cardiac transplantation or have certain infectious diseases like HIV or hepatitis may not benefit from this study.
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 performed: While this approach is focused on sample collection, similar studies have shown success in expediting patient eligibility for clinical trials.
Eligibility criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Adam Armstrong
- Email: clinical@webuildhearts.org
- Phone: (507) 577-1764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.