Exploring energy metabolism in patients with dilated cardiomyopathy
Metabolic Characterization of Patients With Dilated Cardiomyopathy a Prospective Case-control Study
This study is testing how the heart's energy use works in people with dilated cardiomyopathy and heart failure, and whether certain medications can improve it, especially during exercise.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Göteborg University Academic / other |
| Locations | 1 site (Gothenburg, Western Sweden) |
| Trial ID | NCT05284682 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the energy metabolism of the heart in patients suffering from dilated cardiomyopathy (DCM) and heart failure compared to healthy controls. It will involve invasive measurements of energy substrate metabolites in the coronary sinus of the heart. Additionally, the study will assess whether optimal medical therapy, including sodium-glucose transporter 2 inhibitors (SGLT2i), can influence cardiac metabolism in DCM patients. Changes in cardiac metabolism during exercise will also be evaluated.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic heart failure due to dilated cardiomyopathy and reduced ejection fraction.
Not a fit: Patients with life expectancy less than three years due to non-cardiovascular reasons or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of energy metabolism in patients with dilated cardiomyopathy, potentially enhancing treatment strategies.
How similar studies have performed: While the approach of examining cardiac metabolism in heart failure is established, this specific focus on DCM and the use of matched controls is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg, Western Sweden
- Sahlgrenska University Hospital — Gothenburg, Western Sweden, Sweden (Recruiting)
Study contacts
- Principal investigator: Charlotta Ljungman — Sahlgrenska University Hospital
- Study coordinator: Maria Wideqvist
- Email: maria.wideqvist@vgregion.se
- Phone: +46313434416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.