Metabolic Characterization of Patients With Dilated Cardiomyopathy

Launched by GÖTEBORG UNIVERSITY · Mar 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the heart uses energy in patients with dilated cardiomyopathy (DCM), a condition that can lead to heart failure. The main goal is to find out how the energy use in these patients differs from those who do not have heart failure. Researchers also want to see if certain medications, like sodium-glucose transporter 2 inhibitors (SGLT2i), can change how the heart metabolizes energy. Additionally, they will look at how the heart's energy metabolism changes during exercise in patients with DCM.

To participate in this study, you must be at least 18 years old and have chronic heart failure due to DCM. You should have a reduced heart function (measured by a test called LVEF) and be receiving standard medical treatment for heart failure. People with other serious health conditions, diabetes, or certain recent medical procedures may not be eligible. Participants can expect to undergo some invasive tests to measure specific energy substances in their heart during the study. This research aims to improve our understanding of heart failure and potentially lead to better treatments.

Gender

ALL

Eligibility criteria

• • For cases (Heart Failure on the basis of DCM)
• Inclusion Criteria:
• • Signed and dated the Informed Consent Form
• • Male and female subjects ≥18 years of age
• • Chronic Heart failure (HF) with LVEF ≤40%
• • HF due to dilated cardiomyopathy (DCM)
• • New York Heart Association (NYHA) class ≥2
• • Treatment with basic optimal medical therapy.
• • Clinical indication for invasive evaluation of heart failure
• Exclusion Criteria:
• • Life expectancy \< 3 years due to other reasons than cardiovascular, cardiac transplantation or left ventricular assist device
• • Diabetes mellitus type 1 and 2
• • Known hereditary hypercholesterolemia
• • Ongoing lipid lowering therapy
• • Patients on ketogenic diets
• • BMI\>35 or \<19
• • Pregnancy
• • Any current life-threatening cardiac dysrhythmia, cardiac surgery, acute coronary syndrome, or non-elective percutaneous coronary intervention (PCI) \<3 months
• • Current significant major or unstable respiratory disease
• • Considerable hematological disease, hepatic disease, renal disease and/or gastrointestinal disease
• • Stroke, transient ischemic attack, carotid surgery or angioplasty \<3months
• • estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI formula) \<30 mL/min/1.73m2 or patients on renal dialysis
• • Expected inability (by the investigator) to comply with the protocol
• • Subjects incapable to giving consent personally
• • For control subjects (no heart failure)
• Inclusion criteria:
• • Signed and dated Informed Consent Form
• • Male and female subjects ≥18 years of age
• • Clinical indication for electrophysiology examination
• Exclusion criteria:
• • Heart Failure (HFpEF, heart failure with mid-range ejection fraction (HFmrEF) or HFrEF)
• • Life expectancy \< 3 years due to other reasons than cardiovascular, cardiac transplantation or left ventricular assist device
• • Diabetes mellitus type 1 and 2
• • Known hereditary hypercholesterolemia
• • Ongoing lipid lowering therapy
• • Patients on ketogenic diets
• • BMI\>35 or \<19
• • Pregnancy
• • Any current life-threatening cardiac dysrhythmia, cardiac surgery, acute coronary syndrome, or non-elective PCI \<3 months
• • Current significant major or unstable respiratory disease
• • Considerable hematological disease, hepatic disease, renal disease and/or gastrointestinal disease
• • Stroke, transient ischemic attack, carotid surgery or angioplasty \<3months,
• • eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI formula) \<30 mL/min/1.73m2 or patients on renal dialysis
• • Expected inability (by the investigator) to comply with the protocol
• • Subjects incapable to giving consent personally