Clinical Trial

Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy

Study acronym: BRAVE-HEART
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of the BRAVE-HEART study is to learn if an amino acid infusion can reduce the risk of developing acute kidney injury after cardiac surgery in children. The main questions it aims to answer are: 1. Does an amino acid infusion decrease the number of participants with acute kidney injury? 2. Does an amino acid infusion decrease the number of days that participants are on a ventilator after cardiac surgery? Researchers will compare amino acids to a placebo (a look-alike substance that contains no drug) to see if amino acids decrease the number of participants with acute kidney injury. Participants will receive an amino acid or placebo infusion for up to 72 hours starting during cardiac surgery and only while in the operating room or the intensive care unit.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-07-25
notable Sponsor changed: Stuart Goldstein, MD -> Dana Fuhrman 2026-06-18
notable Primary completion pushed: 2026-11 -> 2027-11 2026-06-18
Trial Details
NCT Number NCT07212595
Lead Sponsor Dana Fuhrman
Collaborators: Congenital Heart Alliance of Cincinnati
Conditions Acute Kidney Injury, Mechanical Ventilation
Enrollment 30 participants
Start Date 2026-07-08
Primary Completion 2027-11 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-24