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

NCT07212595 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 001 - BRAVE-HEART
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does an amino acid infusion decrease the number of participants with acute kidney injury?
2. 2.Does an amino acid infusion decrease the number of days that participants are on a ventilator after cardiac surgery?

Conditions

Acute Kidney Injury; Mechanical Ventilation

Keywords

Cardiac Bypass; Pediatric; Acute Kidney Injury; Amino Acids

Outcome Measures

Primary Outcomes (2)

• Rate of acute kidney injury on post-operative days 2, 3, or 4

  The rate of participants randomized to the amino acid infusion developing acute kidney injury as defined by Kidney Disease Improving Global Outcomes (KDIGO) as Stage 1, 2, or 3 will be compared to the rate of acute kidney injury in the placebo group

  From enrollment to post-operative day 4

• Rate of mechanical ventilation at 96 hours post-operatively

  Rate of participants randomized to the amino acid infusion needing invasive mechanical ventilation beyond 96 hours post-operatively from congenital cardiac surgery repair will be compared to the rate from the placebo group.

  From enrollment to 96 hours post-operatively

Study Arms (2)

Acid Acid Infusion

EXPERIMENTAL

Amino Acid Infusion for up to 72 hours

Drug: Amino Acid infusion

Placebo Infusion

PLACEBO COMPARATOR

Placebo Infusion for up to 72 hours

Drug: Lactated ringers solution

Interventions

Amino Acid infusion DRUG

Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours

Also known as: Trophamine(TM) 10%

Acid Acid Infusion

Lactated ringers solution DRUG

Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day

Placebo Infusion

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Expected to be at high risk of developing acute kidney injury after cardiac surgery based on Age, The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score, and anticipated cardiopulmonary bypass time
• Age less than or equal to 18 years
• Weight greater than or equal to 5 kilograms

You may not qualify if:

• Preoperative extracorporeal organ support
• History of chronic kidney disease
• Known or suspected inborn errors of amino acid metabolism
• Known hypersensitivity to amino acids
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3 times the upper limit of normal for age/gender
• Preterm infants less than 6 months of age who were born at less than 36 weeks gestational age
• Anuria at the time of randomization
• Expected use of total parental nutrition (TPN) within the first 72 hours post-operatively

Sponsors & Collaborators

• Stuart Goldstein, MD: lead
• Congenital Heart Alliance of Cincinnati: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Stuart Goldstein, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelli Krallman, RN, BSN, MS

CONTACT

513-636-4837; kelli.krallman@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics; Director, Center for Acute Care Nephrology

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)