Oral L-Carnitine Supplementation in Cardiorenal Heart Failure Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Oral Levocarnitine (L-Carnitine), 2970mg daily dose (990mg taken 3 times a day) for 3 months.
干预措施: Levocarnitine (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: From study start to end of study at 52 weeks
% of eligible patients enrolled over the study period
Retention Rate
时间窗: From enrollment to end of treatment at 6 months
% of enrolled participants completing final follow up
Intervention adherence
时间窗: From enrollment to end of study treatment at 6 months
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.
Safety and Tolerability (adverse events)
时间窗: From enrollment to end of treatment at 6 months
Participants will be monitored throughout the study for any adverse events.
Data Completeness
时间窗: From start of study to end of study at 52 weeks
% of participants with complete data for each outcome
次要结局
- Change in Patient Reported Outcome Measurements (PROM) using the Dynamic Patient Reported Outcome Measure (d/PROM)(From enrollment to the end of treatment at 6 months.)
- Change in cognitive function (Montreal Cognitive Assessment (MoCA))(From enrollment to the end of treatment at 6 months.)
- Change in cognitive function (Creyos)(From enrollment to the end of treatment at 6 months.)
- Change in Patient Reported Outcome Measurements (PROM) using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(From enrollment to the end of treatment at 6 months.)
- Change in Cardiac Function (Echocardiogram)(From enrollment to the end of treatment at 6 months.)
- Change in Functional Capacity (hand-grip strength (HGS)(From enrollment to the end of treatment at 6 months.)
- Change in Functional Capacity (6-minute walk test)(From enrollment to the end of treatment at 6 months.)
- Change in Functional Capacity using Sit to Stand Test (STST)(From enrollment to the end of treatment at 6 months)
研究者
Chris McIntyre
Nephrologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's