NCT07212595

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Stuart Goldstein, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury
• Mechanical Ventilation

Interventions

Type	Name	Description
DRUG	Amino Acid infusion	Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours
DRUG	Lactated ringers solution	Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-11-01
• Completion: 2027-12-31
• First posted: 2025-10-08
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study