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

28 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Kayseri
      • Kayseri, Kayseri, Turquie (Türkiye), 38039
        • Recrutement
        • Erciyes University Faculty of Medicine
        • Contact:
          • MUSTAFA Çalış, MD, Professor, MD, Professor
          • Numéro de téléphone: 22277 +90 352 207 6666
          • E-mail: mcalis@erciyes.edu.tr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Aucune intervention: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in GPX4 Gene Expression
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in SLC7A11 Gene Expression
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Estimé)

15 novembre 2026

Achèvement de l'étude (Estimé)

15 novembre 2026

Dates d'inscription aux études

Première soumission

19 juillet 2026

Première soumission répondant aux critères de contrôle qualité

19 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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