Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy (NCT07212595) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
United States30 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial that hasn't started recruiting yet — given that early-phase studies are still working out safety and dosing details, what does that mean for the level of risk involved if I were to consider participating once it opens?
2The trial is studying amino acid therapy to try to reduce acute kidney injury after surgery — is my situation one where post-operative kidney injury is a real concern, and would this type of intervention even be relevant to my care?
3Since the trial is measuring whether patients are still on mechanical ventilation 96 hours after surgery, does that suggest there's a possibility the amino acid therapy could affect how long I'd need breathing support, and is that something my doctors would monitor closely?
4Are there already standard-of-care approaches to protecting kidney function after surgery that I should know about, and how would joining this trial compare to just receiving those treatments?
5Because this trial isn't recruiting yet, how far out do you think it might open, and is it realistic for someone in my current situation to wait and see if I'd be eligible, or should we be focused on treatment decisions now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of acute kidney injury on post-operative days 2, 3, or 4
Timeframe: From enrollment to post-operative day 4
2
Rate of mechanical ventilation at 96 hours post-operatively
Timeframe: From enrollment to 96 hours post-operatively