Metabolomic Profiling and Comparative Analysis of Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias
Study explores metabolic differences in heart failure patients with arrhythmias
Plain English Summary
Metabolomic Profiling in Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias is a Not Applicable clinical trial sponsored by Muhammed Heja Geçit studying Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy. This study looks at the unique metabolic fingerprints of patients with two types of heart muscle disease (ischemic and non-ischemic cardiomyopathy) who also experience irregular heart rhythms (ventricular arrhythmias). It is for adults diagnosed with heart failure and specific types of irregular heart rhythms. Participation involves providing biospecimens (like blood) for analysis and having their medical information reviewed. Currently, treatment focuses on managing symptoms and arrhythmias; this study aims to find underlying metabolic differences that could lead to new treatments. The trial aims to enroll 60 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a diagnosis of ischemic or non-ischemic cardiomyopathy. Individuals with a weakened heart pump (left ventricular ejection fraction less than 40%). Patients who have had irregular heart rhythms (ventricular tachycardia) confirmed by monitoring devices. People who are able and willing to give consent and provide samples; those with severe liver or kidney disease, active cancer, or recent cardiotoxic treatments are excluded. This trial is studying Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the differences in the body's chemical building blocks (metabolites) between patients with heart damage from blocked arteries versus those with heart damage from other cau The specific primary outcome measures are: Differences in metabolomic pathways between ischemic and non-ischemic cardiomyopathy (Baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it seeks to uncover the distinct metabolic pathways involved in different types of cardiomyopathy with arrhythmias, potentially leading to more targeted treatments for a sig This research targets Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, where improved treatment options are needed.
Investor Insight
This observational study, while not directly testing a new drug, could identify novel biomarkers for risk stratification in a large heart failure market, potentially guiding future therapeutic develop
Is This Trial Right for Me?
Ask your doctor if your specific type of cardiomyopathy and arrhythmia are included in this study. Understand that participation involves providing samples and allowing access to your medical records, with no direct treatment being tested. Be prepared for potential follow-up discussions about your health status and any collected data. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 60 participants
Primary Outcomes
- Differences in metabolomic pathways between ischemic and non-ischemic cardiomyopathy (Baseline)
Secondary Outcomes
- Differences in individual metabolite levels between groups (Baseline)
- Association between metabolomic profiles and clinical parameters (Baseline)
Full Eligibility Criteria
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
Trial Locations
- Istanbul University-Cerrahpasa Cardiology Institute, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
What is clinical trial NCT07507539?
NCT07507539 is a Not Applicable OBSERVATIONAL study titled "Metabolomic Profiling in Ischemic and Non-Ischemic Cardiomyopathy Patients With Ventricular Arrhythmias." It is currently completed and is sponsored by Muhammed Heja Geçit. The trial targets enrollment of 60 participants.
What conditions does NCT07507539 study?
This trial investigates treatments for Heart Failure With Reduced Ejection Fraction (HFrEF), Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy. The primary condition under study is Heart Failure With Reduced Ejection Fraction (HFrEF).
What does Not Applicable mean for NCT07507539?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07507539?
This trial is currently "Completed." It started on 2025-03-02. The estimated completion date is 2026-03-25.
Who is sponsoring NCT07507539?
NCT07507539 is sponsored by Muhammed Heja Geçit. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07507539?
The trial aims to enroll 60 participants. The trial status is completed.
How is NCT07507539 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07507539?
The primary outcome measures are: Differences in metabolomic pathways between ischemic and non-ischemic cardiomyopathy (Baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07507539 being conducted?
This trial is being conducted at 1 site, including Istanbul (Turkey (Türkiye)).
Where can I find official information about NCT07507539?
The official record for NCT07507539 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07507539. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07507539 testing in simple terms?
This study looks at the unique metabolic fingerprints of patients with two types of heart muscle disease (ischemic and non-ischemic cardiomyopathy) who also experience irregular heart rhythms (ventricular arrhythmias). It is for adults diagnosed with heart failure and specific types of irregular heart rhythms.
Why is this trial significant?
This trial matters because it seeks to uncover the distinct metabolic pathways involved in different types of cardiomyopathy with arrhythmias, potentially leading to more targeted treatments for a sig
What are the potential risks of participating in NCT07507539?
The main risk is related to the collection of biospecimens, which may involve minor discomfort or bruising at the sample site. There are no direct treatment risks as this is an observational study; however, the underlying conditions (heart failure, arrhythmias) carry their own risks. Potential side effects are related to the conditions being studied, not the study procedures themselves. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07507539?
Ask your doctor if your specific type of cardiomyopathy and arrhythmia are included in this study. Understand that participation involves providing samples and allowing access to your medical records, with no direct treatment being tested. Be prepared for potential follow-up discussions about your health status and any collected data. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07507539 signal from an investment perspective?
This observational study, while not directly testing a new drug, could identify novel biomarkers for risk stratification in a large heart failure market, potentially guiding future therapeutic develop This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing biospecimens (like blood) for analysis and having their medical information reviewed. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.