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Quantifying New Heart Muscle Cells

A Pilot Study for Quantifying New Heart Muscle Cells

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Days to 1 Year
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study measures how much new heart muscle babies can grow and how this changes with age and heart disease. It is for babies ages 30 days to 1 year who have heart disease and are scheduled for heart surgery likely to remove some heart muscle.

Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration. The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Babies ages 30 days to 1 year.
  • Scheduled for planned heart surgery, not emergency surgery.
  • Have a heart condition likely to require removal of some heart muscle during surgery. This includes tetralogy of Fallot (a group of heart defects) or pulmonary stenosis (a narrowed opening from the heart to the lungs).
  • Heart muscle removed as part of usual surgery can be used for research.

Who can't join

  • Unlikely to have heart muscle removed as part of their surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion. * The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection. * Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research Exclusion Criteria: * Patients with low chance of having resection of myocardium as part of their surgical care.

Study sites (4)

NY

PA