Heart Failure With Reduced Ejection Fraction (HFrEF)MET-CMPNCT07507539
Metabolomic Profiling in Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias
An observational study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Ventricular Tachycardia (VT), run by Muhammed Heja Geçit at 1 site in Turkey (Türkiye).
Trial summary
This single-center prospective observational study aims to evaluate differences in metabolomic pathways between patients with ischemic and non-ischemic cardiomyopathy with reduced left ventricular ejection fraction and documented ventricular tachycardia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2025to 25 Mar 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with ischemic or non-ischemic cardiomyopathy and reduced left ventricular ejection fraction (<40%) who have documented ventricular tachycardia and are followed at Istanbul University-Cerrahpasa Cardiology Institute Hospital.
Who may be able to join
- Age ≥18 years Diagnosis of ischemic or non-ischemic cardiomyopathy Left ventricular ejection fraction <40% Documented ventricular tachycardia detected by Holter monitoring, implantable cardioverter-defibrillator (ICD), pacemaker, or other implantable rhythm monitoring devices Availability of metabolomic sample collection Ability and willingness to provide informed consent
Who cannot join
- History of cardiotoxic chemotherapy or radiotherapy Cirrhosis or advanced hepatic failure Active malignancy Acute decompensated heart failure at presentation Active infection or acute inflammatory disease End-stage renal disease requiring dialysis Absence of Holter monitoring or implantable rhythm monitoring data No documented ventricular tachycardia despite rhythm monitoring Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Cardiology Institute
Istanbul, 34098
About this study
Official title: Metabolomic Profiling and Comparative Analysis of Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias
This single-center prospective observational study aims to evaluate differences in metabolomic pathways between patients with ischemic and non-ischemic cardiomyopathy with reduced left ventricular ejection fraction and documented ventricular tachycardia. Patients followed at Istanbul University-Cerrahpasa Cardiology Institute Hospital will be included if they meet predefined eligibility criteria. Participants will be categorized into two cohorts according to the etiology of cardiomyopathy: ischemic and non-ischemic. Biospecimens will be collected for metabolomic analyses to identify alterations in metabolic pathways and individual metabolites. The study also aims to explore associations between metabolomic profiles and clinical characteristics, including arrhythmia burden and cardiac function parameters. The findings may provide insights into the underlying pathophysiological mechanisms of ventricular arrhythmias in heart failure and contribute to improved risk stratification and personalized management strategies.
Read the detailed description
Heart failure with reduced ejection fraction (HFrEF) is associated with significant metabolic remodeling, reflecting alterations in energy substrate utilization, mitochondrial function, and systemic metabolic pathways. Ventricular tachycardia (VT) remains a major cause of morbidity and mortality in this population. Despite advances in clinical management, the underlying metabolic mechanisms contributing to arrhythmogenesis in ischemic and non-ischemic cardiomyopathy are not fully elucidated.
Metabolomics has emerged as a powerful tool to characterize global metabolic changes and identify disease-specific biochemical signatures. However, comparative metabolomic data between ischemic and non-ischemic cardiomyopathy patients with documented ventricular tachycardia remain limited.
This prospective, single-center observational study aims to compare metabolomic pathways in patients with ischemic and non-ischemic cardiomyopathy with left ventricular ejection fraction below 40% and documented ventricular tachycardia detected by Holter monitoring or implantable cardiac devices. Patients will be recruited from Istanbul University-Cerrahpasa Cardiology Institute Hospital and categorized into two cohorts based on the etiology of cardiomyopathy.
Biological samples will be collected and analyzed using metabolomic approaches to identify differences in metabolic pathways and individual metabolite profiles between the two groups. The primary objective is to determine pathway-level alterations associated with ischemic versus non-ischemic cardiomyopathy in the presence of ventricular tachycardia. Secondary analyses will include evaluation of individual metabolites and their associations with clinical variables such as arrhythmia burden, left ventricular function, and relevant laboratory parameters.
This study is expected to provide novel insights into the metabolic basis of ventricular arrhythmias in heart failure and may contribute to improved risk stratification and the development of personalized therapeutic strategies.
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy
- Keywords
- Metabolomics, Arrhythmia, Ventricular Tachycardia, Heart Failure, HFrEF, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Metabolic Pathways, Biomarkers, Risk Stratification
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic cardiomyopathy | Patients with ischemic cardiomyopathy, left ventricular ejection fraction below 40%, and documented ventricular tachycardia. | |
| Non-ischemic cardiomyopathy | Patients with non-ischemic cardiomyopathy, left ventricular ejection fraction below 40%, and documented ventricular tachycardia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in metabolomic pathways between ischemic and non-ischemic cardiomyopathy
Comparison of metabolomic pathway profiles derived from biospecimen analyses between patients with ischemic and non-ischemic cardiomyopathy with reduced ejection fraction and documented ventricular tachycardia.
Measured: Baseline
Secondary outcomes (2)
Differences in individual metabolite levels between groups
Quantitative comparison of individual metabolite concentrations between ischemic and non-ischemic cardiomyopathy patients using metabolomic analysis techniques.
Measured: Baseline
Association between metabolomic profiles and clinical parameters
Evaluation of correlations between metabolomic findings and clinical variables including left ventricular ejection fraction, arrhythmia burden, and relevant laboratory parameters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start2 Mar 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Muhammed Heja Geçit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammed Heja Geçit, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507539
- Sponsor's protocol ID
- IU-CERRAHPASA-METABOLOMICS-01
- Acronym
- MET-CMP
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiling and Comparative Analysis of Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT07507539
- Acronym / sponsor ID
- MET-CMP / IU-CERRAHPASA-METABOLOMICS-01
- Conditions
- Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy
- Keywords
- Metabolomics, Arrhythmia, Ventricular Tachycardia, Heart Failure, HFrEF, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Metabolic Pathways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muhammed Heja GeçitUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 2 Apr 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.
This single-center prospective observational study aims to evaluate differences in metabolomic pathways between patients with ischemic and non-ischemic cardiomyopathy with reduced left ventricular ejection fraction and documented ventricular tachycardia. Patients followed at Istanbul University-Cerrahpasa Cardiology Institute Hospital will be included if they meet predefined eligibility criteria. Participants will be categorized into two cohorts according to the etiology of cardiomyopathy: ischemic and non-ischemic. Biospecimens will be collected for metabolomic analyses to identify alterations in metabolic pathways and individual metabolites. The study also aims to explore associations between metabolomic profiles and clinical characteristics, including arrhythmia burden and cardiac function parameters. The findings may provide insights into the underlying pathophysiological mechanisms of ventricular arrhythmias in heart failure and contribute to improved risk stratification and personalized management strategies.
Detailed description
Heart failure with reduced ejection fraction (HFrEF) is associated with significant metabolic remodeling, reflecting alterations in energy substrate utilization, mitochondrial function, and systemic metabolic pathways. Ventricular tachycardia (VT) remains a major cause of morbidity and mortality in this population. Despite advances in clinical management, the underlying metabolic mechanisms contributing to arrhythmogenesis in ischemic and non-ischemic cardiomyopathy are not fully elucidated.
Metabolomics has emerged as a powerful tool to characterize global metabolic changes and identify disease-specific biochemical signatures. However, comparative metabolomic data between ischemic and non-ischemic cardiomyopathy patients with documented ventricular tachycardia remain limited.
This prospective, single-center observational study aims to compare metabolomic pathways in patients with ischemic and non-ischemic cardiomyopathy with left ventricular ejection fraction below 40% and documented ventricular tachycardia detected by Holter monitoring or implantable cardiac devices. Patients will be recruited from Istanbul University-Cerrahpasa Cardiology Institute Hospital and categorized into two cohorts based on the etiology of cardiomyopathy.
Biological samples will be collected and analyzed using metabolomic approaches to identify differences in metabolic pathways and individual metabolite profiles between the two groups. The primary objective is to determine pathway-level alterations associated with ischemic versus non-ischemic cardiomyopathy in the presence of ventricular tachycardia. Secondary analyses will include evaluation of individual metabolites and their associations with clinical variables such as arrhythmia burden, left ventricular function, and relevant laboratory parameters.
This study is expected to provide novel insights into the metabolic basis of ventricular arrhythmias in heart failure and may contribute to improved risk stratification and the development of personalized therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic cardiomyopathy | – | –Patients with ischemic cardiomyopathy, left ventricular ejection fraction below 40%, and documented ventricular tachycardia. |
| Non-ischemic cardiomyopathy | – | –Patients with non-ischemic cardiomyopathy, left ventricular ejection fraction below 40%, and documented ventricular tachycardia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with ischemic or non-ischemic cardiomyopathy and reduced left ventricular ejection fraction (<40%) who have documented ventricular tachycardia and are followed at Istanbul University-Cerrahpasa Cardiology Institute Hospital.
Key inclusion criteria (1 listed)
- Age ≥18 years Diagnosis of ischemic or non-ischemic cardiomyopathy Left ventricular ejection fraction <40% Documented ventricular tachycardia detected by Holter monitoring, implantable cardioverter-defibrillator (ICD), pacemaker, or other implantable rhythm monitoring devices Availability of metabolomic sample collection Ability and willingness to provide informed consent
Key exclusion criteria (1 listed)
- History of cardiotoxic chemotherapy or radiotherapy Cirrhosis or advanced hepatic failure Active malignancy Acute decompensated heart failure at presentation Active infection or acute inflammatory disease End-stage renal disease requiring dialysis Absence of Holter monitoring or implantable rhythm monitoring data No documented ventricular tachycardia despite rhythm monitoring Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in metabolomic pathways between ischemic and non-ischemic cardiomyopathy
Time frame: Baseline
Comparison of metabolomic pathway profiles derived from biospecimen analyses between patients with ischemic and non-ischemic cardiomyopathy with reduced ejection fraction and documented ventricular tachycardia.
2 secondary outcomes
Differences in individual metabolite levels between groups
Time frame: Baseline
Association between metabolomic profiles and clinical parameters
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Ventricular Tachycardia (VT), run by Muhammed Heja Geçit 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in metabolomic pathways between ischemic and non-ischemic cardiomyopathy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.