NCT07507539

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 27, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

MetabolomicsArrhythmiaVentricular TachycardiaHeart FailureHFrEFIschemic CardiomyopathyNon-ischemic CardiomyopathyMetabolic PathwaysBiomarkersRisk Stratification

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (2)

  • Differences in individual metabolite levels between groups

    Baseline

  • Association between metabolomic profiles and clinical parameters

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa Cardiology Institute

Istanbul, 34098, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples will be collected from all participants and processed to obtain serum and plasma for metabolomic analyses. Samples will be stored under appropriate conditions and used to evaluate metabolic pathways and individual metabolite profiles.

MeSH Terms

Conditions

Tachycardia, VentricularArrhythmias, CardiacHeart Failure

Condition Hierarchy (Ancestors)

TachycardiaHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiology Resident

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start

March 2, 2025

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations