Heart Failure Clinical Trial
— MECHADOfficial title:
Metabolic Characterization of Patients With Dilated Cardiomyopathy a Prospective Case-control Study
NCT number | NCT05284682 |
Other study ID # | MECHAD |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2022 |
Est. completion date | January 2026 |
The overall aim of the study is to explore the energy metabolism of the failing heart. Primary objective is to understand the differences in the energy metabolism in patients with DCM and heart failure compared to matched controls without heart failure. Secondary objectives, is to understand if optimal medical therapy, including sodium-gucose transporter 2 inhibitors (SGLT2i), alter the cardiac metabolism in DCM-patients. The investigators will also examine if changes in cardiac metabolism happens during exercise in patients with DCM. This will be done with invasive measurements of a range of energy substrate metabolites in the coronary sinus of the heart in patients with heart failure due to DCM and controls without heart failure respectively. A range of other clinical characteristics will also be examined to characterize patients and controls.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | January 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | Western Sweden |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolic markers | Energy substrate metabolic markers in arterial blood and coronary sinus for the calculation of energy metabolism in the myocardium. | through study completion, on average 2 years | |
Secondary | Metabolic markers after medical optimization | Energy substrate metabolic markers in arterial blood and coronary sinus for the calculation of energy metabolism in the myocardium. | through study completion, on average 4 years |
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