Heart FailureAdipoCorNCT07360925
Pericoronary Adipocyte Size Gradient
An observational study of Heart Failure and Heart Transplantation, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Heart Failure, Heart Transplantation
- What is being tested?
- Heart transplantation for the final stage of heart failure
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2023to 1 Jul 2029
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises patients who underwent heart transplantation for heart failure at the Institute for Clinical and Experimental Medicine, Cardiovascular Surgery Department, between June 2023 and December 2028. Only the subjects' ret-rospective clinical data and matching heart samples will be analyzed.
Who may be able to join
- Age 30-90 years
- Diagnosis of dilatational or ischemic cardiomyopathy
- Patients undergoing heart transplantation in IKEM
Who cannot join
- Known combined diagnosis of dilatational and ischemic cardiomyopathy
- Arrhythmogenic cardiomyopathy
- Congenital heart defects
- Non-eligibility due to the absence of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peter Ivak, M.D., PhD, assoc. prof. contact
Czechia1 site, 1 recruiting
- Recruiting
Centre of Experimental Medicine, Institute for Clinical and Experimental Medicine,
Prague, 14021
About this study
Official title: Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue
Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.
Read the detailed description
The project is designed to analyze the impact of inflammation spreading from pericoro-nary adipose tissue to the arterial wall or vice versa. Adipocyte size and immunometabolic parameters gradients established from independent analysis of samples closely adjacent to the coronary artery and those more distant from the arterial lumen will be used to establish the direction of inflammation propagation. The coronary arteries, along with adjacent pericoronary adipose tissue, from explanted hearts will be obtained during heart transplantation of patients with advanced atherosclerosis (ischemic heart disease) and with less advanced atherosclerotic disease (dilated cardiomyopathy).
Clinical data (including age, BMI, comorbidities, and concomitant medications) will be recorded. Specifically, previous left ventricular assist device (LVAD) implantation, used as a bridge-to-transplant approach, will be followed to establish the effect of artificial hemodynamic disturbance on coronary artery blood flow on study endpoints.
- Conditions
- Heart Failure, Heart Transplantation
- Being tested
- Heart transplantation for the final stage of heart failure
- Keywords
- Pericoronary adipose tissue, adipocyte size, inflammatory changes, macrophages
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart transplantation for the final stage of heart failureProcedure or surgery
The study population comprises patients who underwent heart transplantation for heart failure at the Institute for Clinical and Experimental Medicine, Cardiovascular Surgery Department, between June 2023 and December 2028. Only the subjects' retrospective clinical data and matching heart samples will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| patients with advanced heart failure | A group of patients with advanced heart failure were indicated for heart transplanta-tion for either ischemic or dilatational cardiomyopathy. The study group will also in-clude subjects with previously implanted LVAD as a bridge-to-transplant approach. Predictory-related subgroups will be evaluated separately. Receives: Procedure: Heart transplantation for the final stage of heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipocyte size
Assessment of the difference (in square micrometer) between adipocyte size closely adjacent to the coronary artery and those more distant from the arterial lumen in relation to atherosclerotic pathologies in situ
Measured: Perioperative/Periprocedural
Secondary outcomes (2)
Immunological parameters
The immunological characteristics-T cells (counts and percentages), B cells (counts and percentages), macrophages and their subpopulations (counts and percentages)-and the immunohistochemical biomarkers sclerostin, TREM-2 (triggering receptor expressed on myeloid cells 2), and mimecan (score) in the arterial wall and pericoronary adipose tissue (PCAT) will be analyzed and compared.
Measured: Perioperative/Periprocedural
Morphological parameters
The morphological characteristics-atherosclerotic plaque type (category) and calcification rate (percentage)-in the arterial wall and pericoronary adipose tissue (PCAT) will be analyzed and compared.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jun 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ivana Kralova Lesna, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360925
- Sponsor's protocol ID
- AdipoCor2023
- Acronym
- AdipoCor
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue
- ClinicalTrials.gov ID
- NCT07360925
- Acronym / sponsor ID
- AdipoCor / AdipoCor2023
- Conditions
- Heart Failure, Heart Transplantation
- Keywords
- Pericoronary adipose tissue, adipocyte size, inflammatory changes, macrophages
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 22 Jan 2026 (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.
Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.
Detailed description
The project is designed to analyze the impact of inflammation spreading from pericoro-nary adipose tissue to the arterial wall or vice versa. Adipocyte size and immunometabolic parameters gradients established from independent analysis of samples closely adjacent to the coronary artery and those more distant from the arterial lumen will be used to establish the direction of inflammation propagation. The coronary arteries, along with adjacent pericoronary adipose tissue, from explanted hearts will be obtained during heart transplantation of patients with advanced atherosclerosis (ischemic heart disease) and with less advanced atherosclerotic disease (dilated cardiomyopathy).
Clinical data (including age, BMI, comorbidities, and concomitant medications) will be recorded. Specifically, previous left ventricular assist device (LVAD) implantation, used as a bridge-to-transplant approach, will be followed to establish the effect of artificial hemodynamic disturbance on coronary artery blood flow on study endpoints.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with advanced heart failure | – | Procedure: Heart transplantation for the final stage of heart failureA group of patients with advanced heart failure were indicated for heart transplanta-tion for either ischemic or dilatational cardiomyopathy. The study group will also in-clude subjects with previously implanted LVAD as a bridge-to-transplant approach. Predictory-related subgroups will be evaluated separately. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises patients who underwent heart transplantation for heart failure at the Institute for Clinical and Experimental Medicine, Cardiovascular Surgery Department, between June 2023 and December 2028. Only the subjects' ret-rospective clinical data and matching heart samples will be analyzed.
Key inclusion criteria (3 listed)
- Age 30-90 years
- Diagnosis of dilatational or ischemic cardiomyopathy
- Patients undergoing heart transplantation in IKEM
Key exclusion criteria (4 listed)
- Known combined diagnosis of dilatational and ischemic cardiomyopathy
- Arrhythmogenic cardiomyopathy
- Congenital heart defects
- Non-eligibility due to the absence of informed consent
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 |
|---|---|---|
| Heart transplantation for the final stage of heart failureThe study population comprises patients who underwent heart transplantation for heart failure at the Institute for Clinical and Experimental Medicine, Cardiovascular Surgery Department, between June 2023 and December 2028. Only the subjects' retrospective clinical data and matching heart samples will be analyzed. | Procedure or surgery | patients with advanced heart failure |
Primary outcome
Adipocyte size
Time frame: Perioperative/Periprocedural
Assessment of the difference (in square micrometer) between adipocyte size closely adjacent to the coronary artery and those more distant from the arterial lumen in relation to atherosclerotic pathologies in situ
2 secondary outcomes
Immunological parameters
Time frame: Perioperative/Periprocedural
Morphological parameters
Time frame: Perioperative/Periprocedural
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 22 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Peter Ivak, M.D., PhD, assoc. prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Transplantation, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 4 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 22 Jan 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 Czechia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ivana K Lesna, MD, PhD., assoc. prof. (00420236055445, ivana.kralova.lesna@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipocyte size (time frame: Perioperative/Periprocedural). 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 22 Jan 2026.