Coronary Artery Disease (CAD)NCT07722637
The Effect of Cardiac Rehabilitation on Ferroptosis in Patients With Coronary Artery Disease
A study testing Cardiac Rehabilitation in people with Coronary Artery Disease (CAD) and Cardiac Rehab, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD), Cardiac Rehab, Ferroptosis
- What is being tested?
- Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Nov 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine
Kayseri, Kayseri, 38039
MUSTAFA Çalış, MD, Professor, MD, Professor, +90 352 207 6666 ext. 22277, mcalis@erciyes.edu.tr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease (CAD), Cardiac Rehab, Ferroptosis
- Being tested
- Cardiac Rehabilitation
- Keywords
- cardiac rehabilitation, ferroptosis, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation Group | Experimental | 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. Receives: Behavioral: Cardiac Rehabilitation |
| CAD Patients Declining Cardiac Rehabilitation | No intervention | 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. |
| Healthy Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GPX4 Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Secondary outcomes (9)
Change in SLC7A11 Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks)
Change in ACSL4 Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in FSP1 Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in NRF2 Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in TFRC Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in NCOA4 Gene Expression
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Serum Free Iron Concentration
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Serum 4-Hydroxynonenal (4-HNE) Concentration
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Peak Oxygen Uptake (Peak VO₂)
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.
Measured: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jan 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of three parallel groups based on their clinical status and willingness to participate in a cardiac rehabilitation program. The first group will consist of patients with coronary artery disease (CAD) enrolled in a supervised cardiac rehabilitation program. The second group will include patients with CAD who voluntarily decline participation in cardiac rehabilitation and will receive standard medical care without rehabilitation. The third group will comprise age- and sex-matched healthy volunteers without known cardiovascular or chronic diseases. Blood samples will be collected before and after completion of the cardiac rehabilitation program in the rehabilitation group, whereas a single blood sample will be obtained from the non-rehabilitation and healthy control groups. Ferroptosis-related gene expression and serum biomarkers will be compared among the three groups, and pre- and post-rehabilitation changes will be evaluated in patients undergoing c
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Kara, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722637
- Sponsor's protocol ID
- 2025/489
- Other IDs
- TTU-2025-15709
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to make individual participant data from this study publicly available.
Publications
Rao X, Huang X, Zhou Z, Lin X. An improvement of the 2^(-delta delta CT) method for quantitative real-time polymerase chain reaction data analysis. Biostat Bioinforma Biomath. 2013 Aug;3(3):71-85.
PubMed 25558171Cai W, Liu L, Shi X, Liu Y, Wang J, Fang X, Chen Z, Ai D, Zhu Y, Zhang X. Alox15/15-HpETE Aggravates Myocardial Ischemia-Reperfusion Injury by Promoting Cardiomyocyte Ferroptosis. Circulation. 2023 May 9;147(19):1444-1460. doi: 10.1161/CIRCULATIONAHA.122.060257. Epub 2023 Mar 29.
PubMed 36987924Srichaiyapol O, Saiboonjan B, Ngernpimai S, Ponsue C, Sa-Ingthong N, Thongmee P, Wonglakorn L, Sukkasem C, Kendal RP, Daduang J, Tavichakorntrakool R, Srisrattakarn A, Chanawong A, Wongwattanakul M, Lulitanond A, Tippayawat P. Enhanced performances of the short-PCR coupled lateral flow assay in the detection of Candida albicans in clinical blood samples. Asian Pac J Allergy Immunol. 2025 Jun 22. doi: 10.12932/AP-190125-2018. Online ahead of print.
PubMed 40544374Han J, Lin L, Fang Z, Xu D, Wang L, Ye B, Han X, Long X, Min J, Wu G, Liang G, Wang Y. Cardiomyocyte-derived USP13 protects hearts from hypertrophy via deubiquitinating and stabilizing STAT1 in male mice. Nat Commun. 2025 Jul 1;16(1):5927. doi: 10.1038/s41467-025-61028-1.
PubMed 40593642Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP; Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):1-17. doi: 10.1097/HJR.0b013e3283313592.
PubMed 19952757Verdonk ML, Ludlow RF, Giangreco I, Rathi PC. Protein-Ligand Informatics Force Field (PLIff): Toward a Fully Knowledge Driven "Force Field" for Biomolecular Interactions. J Med Chem. 2016 Jul 28;59(14):6891-902. doi: 10.1021/acs.jmedchem.6b00716. Epub 2016 Jul 7.
PubMed 27353137Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
PubMed 26730878Zhang Z, Tang J, Song J, Xie M, Liu Y, Dong Z, Liu X, Li X, Zhang M, Chen Y, Shi H, Zhong J. Elabela alleviates ferroptosis, myocardial remodeling, fibrosis and heart dysfunction in hypertensive mice by modulating the IL-6/STAT3/GPX4 signaling. Free Radic Biol Med. 2022 Mar;181:130-142. doi: 10.1016/j.freeradbiomed.2022.01.020. Epub 2022 Feb 2.
PubMed 35122997Zhou Y, Zhou H, Hua L, Hou C, Jia Q, Chen J, Zhang S, Wang Y, He S, Jia E. Verification of ferroptosis and pyroptosis and identification of PTGS2 as the hub gene in human coronary artery atherosclerosis. Free Radic Biol Med. 2021 Aug 1;171:55-68. doi: 10.1016/j.freeradbiomed.2021.05.009. Epub 2021 May 8.
PubMed 33974977Wang Y, Wu J. Ferroptosis: a new strategy for cardiovascular disease. Front Cardiovasc Med. 2023 Sep 4;10:1241282. doi: 10.3389/fcvm.2023.1241282. eCollection 2023.
PubMed 37731525O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
PubMed 23256914
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ferroptosis-Related Biomarkers in Individuals With Coronary Artery Disease: The Impact of Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT07722637
- Acronym / sponsor ID
- 2025/489
- Conditions
- Coronary Artery Disease (CAD), Cardiac Rehab, Ferroptosis
- Keywords
- cardiac rehabilitation, ferroptosis, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 23 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three parallel groups based on their clinical status and willingness to participate in a cardiac rehabilitation program. The first group will consist of patients with coronary artery disease (CAD) enrolled in a supervised cardiac rehabilitation program. The second group will include patients with CAD who voluntarily decline participation in cardiac rehabilitation and will receive standard medical care without rehabilitation. The third group will comprise age- and sex-matched healthy volunteers without known cardiovascular or chronic diseases. Blood samples will be collected before and after completion of the cardiac rehabilitation program in the rehabilitation group, whereas a single blood sample will be obtained from the non-rehabilitation and healthy control groups. Ferroptosis-related gene expression and serum biomarkers will be compared among the three groups, and pre- and post-rehabilitation changes will be evaluated in patients undergoing c
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation Group | Experimental | Behavioral: Cardiac RehabilitationPatients 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. |
| CAD Patients Declining Cardiac Rehabilitation | No intervention | –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. |
| Healthy Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (20 listed)
- Decompensated heart failure.
- Unstable angina pectoris.
- Uncontrolled or complex ventricular arrhythmias.
- Severe pulmonary hypertension.
- Neurological, orthopedic, or musculoskeletal disorders limiting exercise performance.
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 |
|---|---|---|
| Cardiac RehabilitationA 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. | Behavioural | Cardiac Rehabilitation Group |
Primary outcome
Change in GPX4 Gene Expression
Time frame: 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.
9 secondary outcomes
Change in SLC7A11 Gene Expression
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks)
Change in ACSL4 Gene Expression
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in FSP1 Gene Expression
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in NRF2 Gene Expression
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in TFRC Gene Expression
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in NCOA4 Gene Expression
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Serum Free Iron Concentration
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Serum 4-Hydroxynonenal (4-HNE) Concentration
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
Change in Peak Oxygen Uptake (Peak VO₂)
Time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).
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 29 Jul 2026.
- Background: PubMed 25558171Rao X, Huang X, Zhou Z, Lin X. An improvement of the 2^(-delta delta CT) method for quantitative real-time polymerase chain reaction data analysis. Biostat Bioinforma Biomath. 2013 Aug;3(3):71-85.
- Background: PubMed 36987924Cai W, Liu L, Shi X, Liu Y, Wang J, Fang X, Chen Z, Ai D, Zhu Y, Zhang X. Alox15/15-HpETE Aggravates Myocardial Ischemia-Reperfusion Injury by Promoting Cardiomyocyte Ferroptosis. Circulation. 2023 May 9;147(19):1444-1460. doi: 10.1161/CIRCULATIONAHA.122.060257. Epub 2023 Mar 29.
- Background: PubMed 40544374Srichaiyapol O, Saiboonjan B, Ngernpimai S, Ponsue C, Sa-Ingthong N, Thongmee P, Wonglakorn L, Sukkasem C, Kendal RP, Daduang J, Tavichakorntrakool R, Srisrattakarn A, Chanawong A, Wongwattanakul M, Lulitanond A, Tippayawat P. Enhanced performances of the short-PCR coupled lateral flow assay in the detection of Candida albicans in clinical blood samples. Asian Pac J Allergy Immunol. 2025 Jun 22. doi: 10.12932/AP-190125-2018. Online ahead of print.
- Background: PubMed 40593642Han J, Lin L, Fang Z, Xu D, Wang L, Ye B, Han X, Long X, Min J, Wu G, Liang G, Wang Y. Cardiomyocyte-derived USP13 protects hearts from hypertrophy via deubiquitinating and stabilizing STAT1 in male mice. Nat Commun. 2025 Jul 1;16(1):5927. doi: 10.1038/s41467-025-61028-1.
- Background: PubMed 19952757Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP; Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):1-17. doi: 10.1097/HJR.0b013e3283313592.
- Background: PubMed 27353137Verdonk ML, Ludlow RF, Giangreco I, Rathi PC. Protein-Ligand Informatics Force Field (PLIff): Toward a Fully Knowledge Driven "Force Field" for Biomolecular Interactions. J Med Chem. 2016 Jul 28;59(14):6891-902. doi: 10.1021/acs.jmedchem.6b00716. Epub 2016 Jul 7.
- Background: PubMed 26730878Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
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- Individual participant dataSharing planned: No. It is not planned to make individual participant data from this study publicly available.
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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.
Erciyes University Faculty of Medicine
Kayseri, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation in people with Coronary Artery Disease (CAD) and Cardiac Rehab, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 13 inclusion and 20 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 29 Jul 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GPX4 Gene Expression (time frame: Baseline and immediately after completion of the cardiac rehabilitation program (6 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07722637, which also lists 11 linked publications.
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 29 Jul 2026.