Oral Carnitine in Heart Failure Patients

% of eligible patients enrolled over the study period

% of enrolled participants completing final follow up

Medication compliance measured by the % of prescribed L-carnitine doses taken. Pill counts will be completed at the end of the medication intervention time period at Visit 2.

Participants will be monitored throughout the study for any adverse events.

% of participants with complete data for each outcome

dPROm questionnaire is a digital application patient reported tool which uses a visual analogue scale to measure 3 domains (symptoms, health-related QoL and limitations) using a total of 12 questions. Participants will be assigned a unique unidentifiable username and password and be asked to complete the questionnaire daily over the course of the study.

The MoCA test is a validated and highly sensitive tool for the detection of mild cognitive impairment. The MoCA accurately measures short term memory; visuospatial abilities; executive functions; attention, concentration and working memory; language; and orientation to time and place.

Creyos is an easily administered validated and engaging cognitive assessment. Creyos uses an online platform to deliver scientifically rigorous neurocognitive tasks and batteries based on classical paradigms from cognitive psychology literature. The tests that are used in Creyos are designed to measure cognition in scientific studies and clinical trials. The brain games presented in Creyos encompass testing to assess short-term memory, reasoning, attention and verbal ability.

KCCQ-12 is a validated and standardized commonly used PROM in the heart failure population. It consists of 12 questions that map 7 different domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. Scores are represented on a 0-100-point scale, with lower scores representing more severe symptoms and limitations.

An echocardiogram will be completed at each visit. Images will be captured in the left lateral position and standard apical 2, 3 and 4 chamber views will be recorded for analysis. Three cardiac cycles will be recorded for each time point and values will be derived for segmental and global longitudinal strain.

A Smedley hand grip dynamometer will be used to measure HGS. Participants will be tested in a sitting position with shoulder adducted and neutrally rotated with the elbow flexed at 90o. The participant will be asked to squeeze the handle of the dynamometer as hard as possible for 5 seconds and then relax. The best value out of three attempts will be recorded in kilograms.

The 6-minute walk test measures functional exercise capacity in an objective way. The test procedure is used when a patient would not be able to perform a cardiopulmonary exercise test. (stress test) due to chronic disease (eg Heart Failure)

The sit to stand test has been shown to be a reliable alternative to the 6-minute walk test and may be used in patients who are assessed or who feel that they may not be able to complete a 6-minute walk test due to mobility issues.

A blood sample will be collected at each visit to compare any changes in heart failure and inflammatory markers. (Beta-natriuretic protein (BNP), C-reactive protein (CRP), Cytokine levels, cholesterol panel, Lp (a), albumin, total protein, INR, PTT, creatinine, urea, Trimethylamine N-oxide (TMAO)

A urine sample will be collected at each visit to assess measures of renal and metabolic function. (carnitine, sodium, osmolality, ketone metabolites, myoglobin, TMAO)