Oral Carnitine in Heart Failure Patients

NCT ID: NCT07201714

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure Carnitine Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, interventional, pilot study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Levocarnitine

Intervention Type DRUG

Oral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months.

Interventions

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Levocarnitine

Oral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Chris McIntyre

Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris McIntyre, MBBS DM

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Kathy Koyle

Role: CONTACT

519-685-8500 ext. x 56214

Amy Freeman, RN

Role: CONTACT

519-685-8500 ext. x 55981

Other Identifiers

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16078

Identifier Type: -

Identifier Source: org_study_id

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