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Can a heart drug shield kidneys during bypass surgery?

NCT ID NCT07617675

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 694 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.