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

NCT07212595 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Congenital Heart Alliance of Cincinnati

    collaborator UNKNOWN

  • Stuart Goldstein, MD

    lead OTHER

Principal Investigators

  • Stuart Goldstein, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-11-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212595 on ClinicalTrials.gov