Does Oral Intake of Beta-hydroxybutyrate Decrease Left Ventricular End-systolic Volume at Cardiac Magnetic Resonance in Patients With Heart Failure Compared to Carbohydrate Placebo?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.
研究概览
简要总结
Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo?
详细描述
This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition.
Participants will have 2 different cardiac MRI to perform:
- Fasting with exogenous ketone salt supplement
- Fasting with exogenous carbohydrate supplement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor) Investigators, participants and outcome assessors will be fully blinded.
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
- •Patients with heart failure with left ventricle ejection fraction of 40%
- •Heart failure of ischemic or dilated etiology
- •Ambulatory patient with a NYHA functional class of II-III;
- •Stable symptoms and no change in medical therapy in the last month.
排除标准
- •Patients treated with any SGLT2i;
- •Chronic kidney disease
- •Acute coronary syndrome in the last 3 months;
- •Use of parenteral inotropic agents;
- •Persistent or permanent atrial fibrillation or atrial flutter;
- •Presence of pacemaker or defibrillator;
- •Medical condition that causes malabsorption of the test material;
- •Under ketogenic diet, or using exogenous ketone supplements
- •Use of nicotinamide adenine dinucleotide (NAD) precursor supplements
研究组 & 干预措施
Placebo
干预措施: exogenous carbohydrate supplement (Dietary Supplement)
Ketone
干预措施: exogenous ketone salt supplement (Dietary Supplement)
结局指标
主要结局
Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.
时间窗: 15 minutes
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
次要结局
- Effects of supplement on serum biomarkers(60 minutes)
- Ventricle volume by cardiac MRI after intake supplement in heart failure patients.(15 minutes)
- Effects of supplement on the heart rate of heart failure patients(60 minutes)
- Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.(15 minutes)
- Cardiac output by cardiac MRI after intake supplement in heart failure patients.(15 minutes)
- Effects of supplement on the blood pressure of heart failure patients(60 minutes)