Status:
RECRUITING
Metabolic Characterization of Patients With Dilated Cardiomyopathy
Lead Sponsor:
Göteborg University
Collaborating Sponsors:
Sahlgrenska University Hospital
Conditions:
DCM - Dilated Cardiomyopathy
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 failu...
Detailed Description
Study Design: The MECHAD study is an explorative prospective cohort study with matched controls including patients with heart failure with reduced ejection fraction (HFrEF, EF≤40%) due to DCM in NYHA...
Eligibility Criteria
Inclusion
- For cases (Heart Failure on the basis of DCM)
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05284682
Start Date
March 1 2022
End Date
January 1 2026
Last Update
March 17 2022
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Western Sweden, Sweden, 41345