Oral Carnitine in Heart Failure Patients
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Levocarnitine
DrugOral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
% of eligible patients enrolled over the study period
Time frame
From study start to end of study at 52 weeks2
Retention Rate
% of enrolled participants completing final follow up
Time frame
From enrollment to end of treatment at 6 months3
Intervention adherence
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.
Time frame
From enrollment to end of study treatment at 6 months4
Safety and Tolerability (adverse events)
Participants will be monitored throughout the study for any adverse events.
Time frame
From enrollment to end of treatment at 6 monthsSecondary outcomes
1
Change in Patient Reported Outcome Measurements (PROM) using the Dynamic Patient Reported Outcome Measure (d/PROM)
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.
Time frame
From enrollment to the end of treatment at 6 months.2
Change in cognitive function (Montreal Cognitive Assessment (MoCA))
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.
Time frame
From enrollment to the end of treatment at 6 months.3
Change in cognitive function (Creyos)
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.
Time frame
From enrollment to the end of treatment at 6 months.4
Change in Patient Reported Outcome Measurements (PROM) using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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.
Time frame
From enrollment to the end of treatment at 6 months.Other outcomes
1
Change in serum biomarkers
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)
Time frame
From enrolment to the end of treatment at 6 months.2
Change in urine biomarkers
A urine sample will be collected at each visit to assess measures of renal and metabolic function. (carnitine, sodium, osmolality, ketone metabolites, myoglobin, TMAO)
Time frame
From enrolment to the end of treatment at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov