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The Effect of Cardiac Rehabilitation on Ferroptosis in Patients With Coronary Artery Disease

28 lipca 2026 zaktualizowane przez: Hasan Kara, TC Erciyes University

Evaluation of Ferroptosis-Related Biomarkers in Individuals With Coronary Artery Disease: The Impact of Cardiac Rehabilitation

Coronary artery disease (CAD) remains a major global health concern and is the leading cause of cardiovascular mortality worldwide. Cardiac rehabilitation (CR) is a comprehensive, evidence-based intervention that integrates exercise training with optimal medical management and has been shown to improve clinical outcomes in patients with CAD. The primary objective of this study is to investigate the effects of cardiac rehabilitation on ferroptosis, an iron-dependent form of regulated cell death, in patients with coronary artery disease.

A total of 90 participants will be enrolled in the study after providing written informed consent. The study population will consist of three groups: 30 patients with CAD who participate in a cardiac rehabilitation program, 30 patients with CAD who voluntarily decline participation in cardiac rehabilitation, and 30 age- and sex-matched healthy volunteers without any known chronic disease. Peripheral venous blood samples will be collected from patients undergoing cardiac rehabilitation both before the initiation of the rehabilitation program and upon its completion. A single blood sample will be obtained from patients who decline participation in cardiac rehabilitation and from healthy control participants.

To evaluate ferroptosis-related molecular alterations, the expression levels of the ferroptosis-associated genes GPX4, SLC7A11, ACSL4, FSP1, NRF2, TFRC, and NCOA4 will be analyzed. In addition, serum concentrations of ferroptosis-related biomarkers, including free iron, 4-hydroxynonenal (4-HNE), malondialdehyde (MDA), and GPX4 protein, will be measured. The molecular and biochemical parameters will be compared among the three study groups, and changes in ferroptosis-related biomarkers before and after the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation.

Przegląd badań

Szczegółowy opis

Coronary artery disease (CAD) remains a major global public health challenge and is the leading cause of cardiovascular mortality worldwide. In recent years, ferroptosis, an iron-dependent form of regulated cell death, has emerged as a major focus of biomedical research. Characterized by excessive lipid peroxidation and the accumulation of reactive oxygen species (ROS), ferroptosis has provided new insights into the pathophysiology of CAD and represents a promising therapeutic target.

The pathophysiological significance of ferroptosis in cardiovascular diseases stems from its central role in dysregulated iron metabolism, lipid peroxidation, and excessive ROS accumulation. These mechanisms contribute substantially to the initiation and progression of CAD. Under pathological conditions such as ischemia and hypoxia, cardiomyocytes exhibit increased susceptibility to ferroptosis, leading to cellular dysfunction, myocardial injury, and impaired cardiac function.

Cardiac rehabilitation (CR) is a comprehensive, multidisciplinary intervention that integrates exercise training, cardiovascular risk factor management, lifestyle modification, and psychosocial support, and constitutes a cornerstone of contemporary CAD management. CR has been shown to slow or delay disease progression by targeting modifiable cardiovascular risk factors while improving quality of life, cardiac performance, exercise capacity, and cardiovascular symptoms. Furthermore, CR reduces anxiety, depression, and psychological stress, facilitates return to work, and promotes independence in activities of daily living.

Exercise-based cardiac rehabilitation is among the interventions supported by the strongest evidence for reducing mortality and morbidity in patients with CAD. Experimental studies in animal models have demonstrated that aerobic exercise suppresses ferroptosis, thereby reducing cardiomyocyte death, protecting the ischemic myocardium, and improving cardiac function. Conversely, induction of ferroptosis in cardiomyocytes has been shown to exacerbate ischemia-reperfusion injury. However, no clinical study has comprehensively investigated ferroptosis-related molecular alterations in patients with CAD or evaluated the effects of cardiac rehabilitation on these pathways in humans.

Therefore, the present study aims to compare ferroptosis-related molecular and biochemical biomarkers among patients with CAD undergoing cardiac rehabilitation, patients with CAD who voluntarily decline participation in cardiac rehabilitation, and healthy controls. In addition, changes in ferroptosis-related biomarkers before and after completion of the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Kayseri
      • Kayseri, Kayseri, Turcja (Türkiye), 38039
        • Rekrutacyjny
        • Erciyes University Faculty of Medicine
        • Kontakt:
          • MUSTAFA Çalış, MD, Professor, MD, Professor
          • Numer telefonu: 22277 +90 352 207 6666
          • E-mail: mcalis@erciyes.edu.tr

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

Patients With Coronary Artery Disease (CAD):

  • Age between 18 and 75 years.
  • Diagnosis of coronary artery disease within the previous 3 months.
  • Eligible to participate in a cardiac rehabilitation program or voluntarily decline participation in the cardiac rehabilitation program.
  • Peak exercise capacity of ≥5 metabolic equivalents (METs).
  • Able to undergo cardiopulmonary exercise testing (CPET).
  • Able to understand the study procedures and provide written informed consent.

Healthy Controls:

  • Age between 18 and 75 years.
  • No history of coronary artery disease or other cardiovascular diseases.
  • No history of chronic systemic diseases, including diabetes mellitus, hypertension, chronic kidney disease, chronic liver disease, inflammatory or autoimmune diseases, or malignancy.
  • Not receiving regular medication.
  • Able to provide written informed consent.

Exclusion Criteria:

Patients With Coronary Artery Disease (CAD):

  • Decompensated heart failure.
  • Unstable angina pectoris.
  • Uncontrolled or complex ventricular arrhythmias.
  • Severe pulmonary hypertension.
  • Neurological, orthopedic, or musculoskeletal disorders limiting exercise performance.
  • Absolute contraindications to cardiopulmonary exercise testing or cardiac rehabilitation according to current clinical guidelines.
  • Chronic kidney failure or chronic liver disease.
  • Active infection.
  • Active inflammatory or autoimmune disease.
  • Active malignancy or history of malignancy.
  • Pregnancy.
  • Cognitive or psychiatric disorders that would interfere with study participation or protocol compliance.

Healthy Controls:

  • History of coronary artery disease or other cardiovascular diseases.
  • History of chronic systemic diseases, including diabetes mellitus, hypertension, chronic kidney disease, chronic liver disease, inflammatory or autoimmune diseases, or malignancy.
  • Regular medication use within the previous 6 months.
  • Active infection.
  • Pregnancy.
  • Age younger than 18 years or older than 75 years.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Cardiac Rehabilitation Group
Patients with coronary artery disease who will participate in a supervised cardiac rehabilitation program in addition to standard medical therapy. Peripheral venous blood samples will be collected before the initiation and after completion of the cardiac rehabilitation program for the assessment of ferroptosis-related gene expression and serum biomarkers.
A supervised, comprehensive cardiac rehabilitation program consisting of individualized aerobic and resistance exercise training, patient education, lifestyle modification, and cardiovascular risk factor management according to current clinical practice guidelines.
Brak interwencji: CAD Patients Declining Cardiac Rehabilitation
Patients with coronary artery disease who voluntarily decline participation in the cardiac rehabilitation program and continue to receive standard medical therapy. A single peripheral venous blood sample will be collected for the assessment of ferroptosis-related gene expression and serum biomarkers.
Brak interwencji: Healthy Control Group
Age- and sex-matched healthy volunteers without known cardiovascular or chronic diseases. A single peripheral venous blood sample will be collected for the assessment of ferroptosis-related gene expression and serum biomarkers.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in GPX4 Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
elative GPX4 gene expression in peripheral blood will be quantified using real-time quantitative polymerase chain reaction (RT-qPCR). Changes in GPX4 gene expression before and after completion of the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation. Baseline GPX4 gene expression levels will also be compared among patients undergoing cardiac rehabilitation, patients who decline participation in cardiac rehabilitation, and healthy control participants.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in SLC7A11 Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks)
Relative SLC7A11 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks)
Change in ACSL4 Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Relative ACSL4 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in FSP1 Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Relative FSP1 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in NRF2 Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Relative NRF2 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in TFRC Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Relative TFRC gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in NCOA4 Gene Expression
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Relative NCOA4 gene expression will be measured using RT-qPCR. Expression levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Serum Free Iron Concentration
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Serum free iron concentration will be measured using a validated laboratory assay. Levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Serum 4-Hydroxynonenal (4-HNE) Concentration
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Serum 4-hydroxynonenal concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Levels will be compared among the three study groups, and changes before and after cardiac rehabilitation will be evaluated in the rehabilitation group.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Peak Oxygen Uptake (Peak VO₂)
Ramy czasowe: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Peak oxygen uptake (Peak VO₂) will be assessed using a symptom-limited cardiopulmonary exercise test (CPET). Changes in Peak VO₂ before and after completion of the cardiac rehabilitation program will be evaluated in patients undergoing cardiac rehabilitation. Baseline Peak VO₂ values will also be compared between patients undergoing cardiac rehabilitation and patients who decline participation in cardiac rehabilitation.
Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2026

Zakończenie podstawowe (Szacowany)

15 listopada 2026

Ukończenie studiów (Szacowany)

15 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

19 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 lipca 2026

Pierwszy wysłany (Rzeczywisty)

23 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

It is not planned to make individual participant data from this study publicly available.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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