Acute Kidney InjuryPhase 2BRAVE-HEARTNCT07212595
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
A Phase 2 study testing Amino Acid infusion and Lactated ringers solution in people with Acute Kidney Injury and Mechanical Ventilation, run by Dana Fuhrman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Kidney Injury, Mechanical Ventilation
- What is being tested?
- Amino Acid infusion and Lactated ringers solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Clinical Research Manager, 513-636-4837, kelli.krallman@cchmc.org
Stuart Goldstein, MD
About this study
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:
- Does an amino acid infusion decrease the number of participants with acute kidney injury?
- Does an amino acid infusion decrease the number of days that participants are on a ventilator after cardiac surgery?
Read more
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
- Being tested
- Amino Acid infusion, Lactated ringers solution
- Keywords
- Cardiac Bypass, Pediatric, Acute Kidney Injury, Amino Acids
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid infusionDrug
Also called Trophamine(TM) 10%
Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours
Lactated ringers solutionDrug
Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day
| Study group | Role | What they receive |
|---|---|---|
| Acid Acid Infusion | Experimental | Amino Acid Infusion for up to 72 hours Receives: Drug: Amino Acid infusion |
| Placebo Infusion | Placebo comparator | Placebo Infusion for up to 72 hours Receives: Drug: Lactated ringers solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From enrollment to 96 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start8 Jul 2026
- Primary completionNov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana Fuhrman
- Sponsor type
- University, hospital or other
- Collaborators
- Congenital Heart Alliance of Cincinnati
- Responsible party
- Sponsor-investigator, Dana Fuhrman, Children's Hospital Medical Center, Cincinnati
- Investigators
- Stuart Goldstein, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212595
- Sponsor's protocol ID
- 001 - BRAVE-HEART
- Acronym
- BRAVE-HEART
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: With a small data set from a single center, there is a high risk of the participants being able to be re-identified with the details within the data set.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
- ClinicalTrials.gov ID
- NCT07212595
- Acronym / sponsor ID
- BRAVE-HEART / 001 - BRAVE-HEART
- Conditions
- Acute Kidney Injury, Mechanical Ventilation
- Keywords
- Cardiac Bypass, Pediatric, Acute Kidney Injury, Amino Acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana FuhrmanUniversity, hospital or other
- Collaborators
- Congenital Heart Alliance of Cincinnati
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does an amino acid infusion decrease the number of participants with acute kidney injury?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acid Acid Infusion | Experimental | Drug: Amino Acid infusionAmino Acid Infusion for up to 72 hours |
| Placebo Infusion | Placebo comparator | Drug: Lactated ringers solutionPlacebo Infusion for up to 72 hours |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino Acid infusionAlso: Trophamine(TM) 10%Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours | Drug | Acid Acid Infusion |
| Lactated ringers solutionPlacebo infusion to match the volume of the amino acid infusion in grams/kilogram/day | Drug | Placebo Infusion |
Primary outcome
Rate of acute kidney injury on post-operative days 2, 3, or 4
Time frame: From enrollment to post-operative day 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
Rate of mechanical ventilation at 96 hours post-operatively
Time frame: From enrollment to 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. With a small data set from a single center, there is a high risk of the participants being able to be re-identified with the details within the data set.
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stuart Goldstein, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amino Acid infusion and Lactated ringers solution in people with Acute Kidney Injury and Mechanical Ventilation, run by Dana Fuhrman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelli Krallman, RN, BSN, MS (513-636-4837, kelli.krallman@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute kidney injury on post-operative days 2, 3, or 4 (time frame: From enrollment to post-operative day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.