Can a heart drug shield kidneys during bypass surgery?
NCT ID NCT07617675
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called recombinant human brain natriuretic peptide (rhBNP), given continuously during and after heart surgery, can prevent acute kidney injury. It includes 694 high-risk adults undergoing elective heart surgery with a heart-lung machine. Participants receive either the drug or a placebo for about 48 hours, and researchers track kidney function for a week.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human brain natriuretic peptide (rhBNP)
- What this could lead to
- If it works, this could provide a way to prevent kidney damage during heart surgery, reducing hospital stays and improving recovery.
- What could go wrong
- This is a Phase 4 trial, but results are not yet available. The drug may not prevent kidney injury as hoped, and side effects like low blood pressure are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 694 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass * Presence of at least one of the following AKI risk factors: * Age ≥ 70 years * Preoperative renal impairment (eGFR ≤ 60 mL/min/1.73 m² or urine protein ≥ +2 at screening) * Type 2 diabetes mellitus * Heart failure, defined as NYHA Class II-IV with NT-proBNP ≥ 125 pg/mL at screening; for participants with atrial fibrillation, NT-proBNP ≥ 365 pg/mL is required * Able to understand and provide written informed consent, and willing and able to comply with all study protocol requirements Exclusion Criteria: * Cardiogenic shock * Severe hypotension (systolic blood pressure ≤ 90 mmHg) at screening * Restrictive or obstructive cardiomyopathy, pericarditis, or cardiac tamponade * Preoperative chronic kidney disease stage 4 or higher (eGFR \< 30 mL/min/1.73 m²), or renal instability as judged by the investigator * Known AKI diagnosed per KDIGO criteria within 48 hours prior to surgery * Receipt of any form of renal replacement therapy within 30 days prior to surgery * Use of ventricular assist device, intra-aortic balloon pump, or any other mechanical cardiac support device within 7 days prior to surgery * Chronic hepatic insufficiency (Child-Pugh Class B or C) or hepatic dysfunction (ALT or AST \> 2× upper limit of normal \[ULN\], or total bilirubin \> 1.5× ULN) * Active hepatitis B (HBsAg positive with HBV-DNA indicating active viral replication), active hepatitis C (HCV antibody positive with HCV-RNA indicating active viral replication), positive syphilis screen, known HIV infection, or positive HIV test * Confirmed or treated endocarditis, sepsis, or active infection requiring antibiotic treatment within 30 days prior to surgery * Requirement for aortic dissection repair, complex congenital heart surgery, emergency surgery, or life-saving surgery * History of malignant tumor, solid tumor, metastatic tumor, or hematological malignancy within the past 5 years * Prior organ transplantation or current use of immunosuppressive agents * Any condition that may conflict with or contraindicate the use of intravenous vasodilator therapy * Prior adverse reaction to nesiritide (recombinant BNP) * Participation in any other clinical trial within 30 days prior to surgery * Pregnant or breastfeeding women * Any other condition that, in the judgment of the investigator, renders the participant unsuitable for study participation
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Get notified about this study
Sign up to get updates when this study changes or when new studies for AKI - acute kidney injury are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Eye ultrasound may spot brain swelling during aortic surgery
- Minute-by-Minute urine tracking may sharpen fluid care after heart surgery
- Can acupuncture needles calm the Body's Post-Surgery fire?
- Ultrasound could guide safer fluid dosing after heart surgery
- Could a simple blood test guard against organ damage in heart surgery?