[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608450":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":71,"studyPopulation":68,"armGroups":72,"interventions":79,"overallOfficials":85,"centralContacts":90,"locations":101,"responsibleParty":115,"collaborators":68,"id":118,"slug":68,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":68,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":68,"enrollmentInfo":126,"targetDuration":68,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":68,"overallStatus":103,"whyStopped":68,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":55},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"Recruitment Rate","% of eligible patients enrolled over the study period","From study start to end of study at 52 weeks",{"measure":14,"description":15,"timeFrame":16},"Retention Rate","% of enrolled participants completing final follow up","From enrollment to end of treatment at 6 months",{"measure":18,"description":19,"timeFrame":20},"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.","From enrollment to end of study treatment at 6 months",{"measure":22,"description":23,"timeFrame":16},"Safety and Tolerability (adverse events)","Participants will be monitored throughout the study for any adverse events.",{"measure":25,"description":26,"timeFrame":27},"Data Completeness","% of participants with complete data for each outcome","From start of study to end of study at 52 weeks",[29,33,36,39,42,45,48,51],{"measure":30,"description":31,"timeFrame":32},"Change in Patient Reported Outcome Measurements (PROM) using the Dynamic Patient Reported Outcome Measure (d\u002FPROM)","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.","From enrollment to the end of treatment at 6 months.",{"measure":34,"description":35,"timeFrame":32},"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.",{"measure":37,"description":38,"timeFrame":32},"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.",{"measure":40,"description":41,"timeFrame":32},"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.",{"measure":43,"description":44,"timeFrame":32},"Change in Cardiac Function (Echocardiogram)","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.",{"measure":46,"description":47,"timeFrame":32},"Change in Functional Capacity (hand-grip strength (HGS)","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.",{"measure":49,"description":50,"timeFrame":32},"Change in Functional Capacity (6-minute walk test)","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)",{"measure":52,"description":53,"timeFrame":54},"Change in Functional Capacity using Sit to Stand Test (STST)","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.","From enrollment to the end of treatment at 6 months",[56,60],{"measure":57,"description":58,"timeFrame":59},"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)","From enrolment to the end of treatment at 6 months.",{"measure":61,"description":62,"timeFrame":59},"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)",{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":67,"observationalModel":68,"timePerspective":68,"maskingInfo":69},"NA","SINGLE_GROUP","Prospective, interventional, pilot study","HEALTH_SERVICES_RESEARCH",null,{"masking":70,"maskingDescription":68,"whoMasked":68},"NONE","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.",[73],{"label":74,"type":75,"description":76,"interventionNames":77},"Intervention","EXPERIMENTAL","Oral Levocarnitine (L-Carnitine), 2970mg daily dose (990mg taken 3 times a day) for 3 months.",[78],"Drug: Levocarnitine",[80],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":68},"DRUG","Levocarnitine","Oral L-carnitine, 2970mg daily (950mg, to be taken 3 times a day) for 3 months.",[74],[86],{"name":87,"affiliation":88,"role":89},"Chris McIntyre, MBBS DM","London Health Sciences Centre","PRINCIPAL_INVESTIGATOR",[91,97],{"name":92,"role":93,"phone":94,"phoneExt":95,"email":96},"Kathy Koyle","CONTACT","519-685-8500","x 56214","kathleen.koyle@lhsc.on.ca",{"name":98,"role":93,"phone":94,"phoneExt":99,"email":100},"Amy Freeman, RN","x 55981","amy.freeman@lhsc.on.ca",[102],{"facility":88,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":68},"RECRUITING","London","Ontario","N6A 5W9","Canada","CA",{"type":110,"coordinates":111},"Point",[112,113],-81.23304,42.98339,{"lat":113,"lon":112},{"type":89,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":68,"oldOrganization":68},"Chris McIntyre","Nephrologist","100608450",false,"NCT07201714","Oral Carnitine in Heart Failure Patients","Oral L-Carnitine Supplementation in Cardiorenal Heart Failure Patients","Inclusion Criteria:\n\n* Clinical-pathological diagnosis of heart failure with some degree of cardiorenal syndrome\n* Stage 1, 2, 3a, 3b, or 4 chronic kidney disease\n* Age ≥ 18 years\n* Able to speak and read English\n* Willing and able to provide consent\n\nExclusion Criteria:\n\n* Estimated GFR \\\u003C15 mL\u002Fmin\u002F1.73m2 or Stage 5 chronic kidney disease\n* Currently undergoing renal replacement therapy of any kind\n* Pregnant, breastfeeding or intending pregnancy\n* History of seizures of any type\n* Known allergy to levocarnitine, magnesium stearate, microcrystalline cellulose or povidone\n* Unable to provide consent","ALL","18 Years",{"count":127,"type":128},20,"ESTIMATED","INTERVENTIONAL",[131],"EARLY_PHASE1","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.",[134,135],"Heart Failure","Carnitine Deficiency","2026-04-15",{"date":138,"type":139},"2026-04-20","ACTUAL",{"date":141,"type":139},"2025-11-12",{"date":143,"type":128},"2026-12-31",{"name":5,"class":6},1]