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New treatment option for Non-ischemic Dilated Cardiomyopathy
Official title High Fat Diet for Cardiac Metabolic Reprogramming
ClinicalTrials.gov ID: NCT06747429
What this study is testing
- What it's testing
- Heart failure (HF) continues to be a leading cause of morbidity and mortality worldwide, despite advances in treatment. HF is often characterized by an altered metabolism in the heart, where glucose is favored over fatty acids as the primary energy substrate.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients of both sexes and ≥18 years old
- Patients diagnosed with HF secondary to non-ischemic DCM, according to ESC guidelines definition,1 with or without a known genetic basis.
- LVEF ≤49% according to the baseline CMR.
- Optimized HF guideline-directed medical therapy for at least 3 months prior to inclusion.
- Patients who have provided informed consent.
You likely can't join if
- Prior diagnosis of ischemic DCM.
- Prior diagnosis of established atherosclerotic cardiovascular disease (angina/myocardial infarction, transient ischemic attack/stroke, lower limb...
- Changes in HF therapies within the last 3 months.
- HF decompensation within the previous 3 months, including HF hospitalization or the need of ambulatory intravenous diuretic or inotropic treatment...
- Uncontrolled dyslipidemia, defined as LDL-cholesterol \>160 mg/dL and/or triglycerides \>200 mg/dL, despite treatment.
- Any contraindication for CMR: Severe claustrophobia. Any device which is known to threaten or pose hazard in all MR environments...
See the full eligibility criteria
- Patients of both sexes and ≥18 years old
- Patients diagnosed with HF secondary to non-ischemic DCM, according to ESC guidelines definition,1 with or without a known genetic basis.
- LVEF ≤49% according to the baseline CMR.
- Optimized HF guideline-directed medical therapy for at least 3 months prior to inclusion.
- Patients who have provided informed consent.
- Prior diagnosis of ischemic DCM.
- Prior diagnosis of established atherosclerotic cardiovascular disease (angina/myocardial infarction, transient ischemic attack/stroke, lower limb ischemia or at any other peripheral level).
- Changes in HF therapies within the last 3 months.
- HF decompensation within the previous 3 months, including HF hospitalization or the need of ambulatory intravenous diuretic or inotropic treatment such as levosimendan.
- Uncontrolled dyslipidemia, defined as LDL-cholesterol \>160 mg/dL and/or triglycerides \>200 mg/dL, despite treatment.
- Any contraindication for CMR: Severe claustrophobia. Any device which is known to threaten or pose hazard in all MR environments. //www.mrisafety.com/ Patients with implanted biomedical devices (cardiac artefacts)...
- Liver and biliary diseases, including prior diagnosis of non-alcoholic fatty liver disease and unoperated cholelithiasis.
- Prior episodes of acute pancreatitis or chronic pancreatitis.
- Prior fish or nut allergy.
- Life expectancy less than 12 months.
- Pregnancy or planned pregnancy for the next 4 months.
- Current lactation.
- Patients participating in other assigned by chance clinical trial.
- Impossibility to consent or undergo study follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Florence, Italy
- Bucharest, Romania
- Madrid, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Florence, Italy; Bucharest, Romania; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.