NCT07360925

Brief Summary

Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
38mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jun 2023Jul 2029

Study Start

First participant enrolled

June 1, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

Pericoronary adipose tissueadipocyte sizeinflammatory changesmacrophages

Outcome Measures

Primary Outcomes (1)

  • 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

    Perioperative/Periprocedural

Secondary Outcomes (2)

  • Immunological parameters

    Perioperative/Periprocedural

  • Morphological parameters

    Perioperative/Periprocedural

Study Arms (1)

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.

Procedure: Heart transplantation for the final stage of heart failure

Interventions

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.

patients with advanced heart failure

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 30-90 years
  • Diagnosis of dilatational or ischemic cardiomyopathy
  • Patients undergoing heart transplantation in IKEM

You may not qualify if:

  • Known combined diagnosis of dilatational and ischemic cardiomyopathy
  • Arrhythmogenic cardiomyopathy
  • Congenital heart defects
  • Non-eligibility due to the absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Experimental Medicine, Institute for Clinical and Experimental Medicine,

Prague, 14021, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Coronary artery segment with adjacent tissues

MeSH Terms

Conditions

Heart Failure

Interventions

Heart Transplantation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical ProceduresOrgan TransplantationTransplantation

Central Study Contacts

Ivana K Lesna, MD, PhD., assoc. prof.

CONTACT

Peter Ivak, M.D., PhD, assoc. prof.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ivana Kralova Lesna, M.D., PhD., assoc. prof.

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 22, 2026

Study Start

June 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations