Blood test may replace painful heart biopsies for transplant patients
NCT ID NCT07531784
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a blood test that measures donor DNA can detect rejection in heart transplant patients. Researchers will compare the test results with standard heart biopsies in 120 adults across Sweden. If the test works well, it could offer a less invasive way to monitor for rejection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor-derived cell-free DNA blood test
- What this could lead to
- If successful, this blood test could replace some invasive heart biopsies, making rejection monitoring safer and easier for transplant patients.
- What could go wrong
- This is an observational study, not a treatment trial. The test may not be accurate enough to replace biopsies, and results may vary between patients.
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.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will include adult HTx recipients from Skåne University Hospital (Lund), Sahlgrenska University Hospital (Gothenburg), and Karolinska University Hospital (Stockholm). All participants undergo endomyocardial biopsies as part of routine post-transplant surveillance. Heart transplantations are performed at Skåne University Hospital or Sahlgrenska University Hospital, with post-transplant follow-up conducted at the outpatient transplant clinics at the participating centers.
- 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: * Adults (≥18 years) who undergo orthotopic HTx. Exclusion Criteria: * Pregnancy, * Multi-organ transplantation * Solid organ * Hematopoietic stem cell transplantation.
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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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Karolinska University Hospital
RECRUITINGStockholm, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Thymus cells may teach a new heart to be left alone
- Can a new care pathway speed up advanced heart failure decisions?
- Can a transition program keep young heart transplant patients on track?
- New study aims to spot heart transplant rejection without a biopsy
- Simple saltwater solution may shield kidneys after heart transplant
- Heart transplant study aims to uncover hidden blood flow clues