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Recruiting NCT07201714

Oral Carnitine in Heart Failure Patients

Early Phase I Interventional Heart Failure Carnitine Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levocarnitine.
Who it may be relevant to
Registry conditions: Heart Failure, Carnitine Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Oral L-Carnitine Supplementation in Cardiorenal Heart Failure Patients

Overview

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

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.

Interventions

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

Primary outcome measures

  • Recruitment Rate [Time frame: From study start to end of study at 52 weeks]
  • Retention Rate [Time frame: From enrollment to end of treatment at 6 months]
  • Intervention adherence [Time frame: From enrollment to end of study treatment at 6 months]
  • Safety and Tolerability (adverse events) [Time frame: From enrollment to end of treatment at 6 months]
  • Data Completeness [Time frame: From start of study to end of study at 52 weeks]
Secondary outcome measures (8)
  • Change in Patient Reported Outcome Measurements (PROM) using the Dynamic Patient Reported Outcome Measure (d/PROM) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in cognitive function (Montreal Cognitive Assessment (MoCA)) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in cognitive function (Creyos) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Patient Reported Outcome Measurements (PROM) using Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Cardiac Function (Echocardiogram) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Functional Capacity (hand-grip strength (HGS) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Functional Capacity (6-minute walk test) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Functional Capacity using Sit to Stand Test (STST) [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Identifiers

NCT: NCT07201714 · 16078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗