Metabolomic Profiling in Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias (MET-CMP)

March 27, 2026 updated by: Muhammed Heja Geçit

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul University-Cerrahpasa Cardiology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in individual metabolite levels between groups
Time Frame: Baseline
Quantitative comparison of individual metabolite concentrations between ischemic and non-ischemic cardiomyopathy patients using metabolomic analysis techniques.
Baseline
Association between metabolomic profiles and clinical parameters
Time Frame: Baseline
Evaluation of correlations between metabolomic findings and clinical variables including left ventricular ejection fraction, arrhythmia burden, and relevant laboratory parameters.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammed Heja Geçit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2025

Primary Completion (Actual)

March 25, 2026

Study Completion (Actual)

March 25, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU-CERRAHPASA-METABOLOMICS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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