NIH-funded research R01 grant

Digoxin effects in infants with single‑ventricle heart failure

Official title: Digoxin Pharmacodynamics in Infants with Heart Failure due to Single Ventricle Congenital Heart Disease

Funded at Duke University · NIH-11045660 · Data updated 2026-11-12

This project looks at how the heart drug digoxin behaves and affects newborns and infants who have heart failure from single‑ventricle congenital heart disease.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionDuke University
NIH-funded
Lab location1 site (Durham, United States)
Project startApril 1, 2022
Project endFebruary 28, 2027
Funding year2026
Award (this year)$661,643
NIH project number5R01HD106588-04
Project IDNIH-11045660 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are newborns and infants with single‑ventricle congenital heart disease who have heart failure and who are receiving or may receive digoxin as part of their care.

Less likely to help

Children without single‑ventricle heart disease, older children or adults, or patients who will not receive digoxin are unlikely to benefit directly from this work.

What this research studies

If your baby has single‑ventricle heart disease and heart failure, this work would measure digoxin levels in the blood, check kidney function, and watch how the heart responds while on the medicine. Doctors will collect small blood samples, clinical measurements, and chart information during routine care and use those data to map how dose, growth, and illness change drug exposure and effect. The team will use those measurements to build models that predict safe and effective dosing for different ages and clinical situations. The goal is to reduce guessing about dosing and to help clinicians give the right amount of digoxin to infants with this condition.

Why it matters

Potential benefit: If successful, this could lead to safer, more accurate digoxin dosing and potentially fewer deaths or transplants among infants with single‑ventricle heart failure.

How similar studies have gone: Retrospective studies suggested digoxin may improve survival in infants with single‑ventricle disease, but prospective pharmacokinetic/pharmacodynamic studies in this population are new.

Where this research is happening

  • Duke University
    Durham, United States
    Active

Researchers

  • Principal investigator: Hornik, Christoph — Duke University
  • Study coordinator: Hornik, Christoph

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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.