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

28 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Kayseri
      • Kayseri, Kayseri, Turquía (Türkiye), 38039
        • Reclutamiento
        • Erciyes University Faculty of Medicine
        • Contacto:
          • MUSTAFA Çalış, MD, Professor, MD, Professor
          • Número de teléfono: 22277 +90 352 207 6666
          • Correo electrónico: mcalis@erciyes.edu.tr

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Sin intervención: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in GPX4 Gene Expression
Periodo de tiempo: 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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in SLC7A11 Gene Expression
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2026

Finalización primaria (Estimado)

15 de noviembre de 2026

Finalización del estudio (Estimado)

15 de noviembre de 2026

Fechas de registro del estudio

Enviado por primera vez

19 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de julio de 2026

Publicado por primera vez (Actual)

23 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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