Oral Carnitine in Heart Failure Patients

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Carnitine Deficiency; Heart Failure

Treatments: Drug: Levocarnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT07201714

16078

Details and patient eligibility

About

Heart failure is a condition in which the heart is unable to pump blood effectively, leading to symptoms like being more tired, shortness of breath, and swelling in the body. Carnitine is a naturally occurring substance in the body that plays a role in turning fat into energy. This study will determine whether oral L-Carnitine supplementation can improve symptoms, enhance heart function and possibly improve the quality of life in individuals with heart failure.

Full description

Heart failure (HF) is a multi-organ syndrome that is fundamentally driven by metabolic failure. Metabolic alterations include reduced fatty acid oxidation, which is the main fuel source for cardiac myocyctes in normal circumstances. Carnitine is a vitamin-like modified amino acid that is essential in the oxidation of fatty acids and has been found to be reduced in the heart failure population. Abnormalities in carnitine metabolism are thought to contribute to myocardial dysfunction, oxidative stress and inflammation. Carnitine supplementation may increase fatty acid oxidation, and therefore energy metabolism in heart failure patients, thus improving functional capacity, clinical measures and quality of life in this vulnerable patient population.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical-pathological diagnosis of heart failure with some degree of cardiorenal syndrome
• Stage 1, 2, 3a, 3b, or 4 chronic kidney disease
• Age ≥ 18 years
• Able to speak and read English
• Willing and able to provide consent

Exclusion criteria

• Estimated GFR <15 mL/min/1.73m2 or Stage 5 chronic kidney disease
• Currently undergoing renal replacement therapy of any kind
• Pregnant, breastfeeding or intending pregnancy
• History of seizures of any type
• Known allergy to levocarnitine, magnesium stearate, microcrystalline cellulose or povidone
• Unable to provide consent

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention

Experimental group

Description:

Oral Levocarnitine (L-Carnitine), 2970mg daily dose (990mg taken 3 times a day) for 3 months.

Treatment:

Drug: Levocarnitine