Assessment of the Clinical Effects of Triheptanoin Oil to Target Cardiac Anaplerosis in Congestive Heart Failure- Acute Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cardiac output/index
研究概览
简要总结
Patients with dilated cardiomyopathy who present for indwelling right heart catheterization will be enrolled and randomized to either control or triheptanoin oil for five days. Hemodynamics will be assess serially.
详细描述
Consecutive patients with DCM presenting for a right heart catheterization will be enrolled. All patients will be presenting electively for hemodynamic assessment and will have their PA catheter left in place after their catheterization as part of their usual care. Post-procedure, patients will be monitored in the coronary care unit, which is routine for patients with these catheters. Patients will be approached for potential enrollment in the study protocol. The goal enrollment for this phase of the protocol is 24 patients (12 participants receiving triheptanoin and 10 receiving placebo).
Patients will randomly be assigned to receive either triheptanoin oil or control treatment (sugar syrup) four times a day one hour before meals and at night for five days. All patients will be given a low fat, low simple sugar diet to avoid potential substrate competition from high serum levels of fats and glucose for the duration of the study procedure. Participants will be blinded to their treatment assignment.
Treatment arm: The standard dose of triheptanoin oil for adults is 1-2gm/kg/24 hours. For purposes of this study, we will administer 0.25mg/kg four-times per day. The liquid study drug will be mixed into sugar-free, low fat yogurt, pudding or nutritional supplement shake, depending on patient preference.
Control arm: One tablespoon of sugar syrup will be mixed into sugar-free, low fat yogurt, pudding or nutritional supplement shake four-times per day before meals.
Thermodilution cardiac index and PCWP will be measured from the indwelling PA catheter at baseline and hourly for the first six hours. During this time, initiation or upward titration of vasodilator and inotropic mediations will be discouraged although the medications will be continued in patients previously on these medications. Patients requiring such vasoactive medications on an urgent basis will have been excluded from study participation (see below). After the first six hours, measurements will be recorded once a day, 90 minutes following ingestion of study medication for the four days of treatment, as well as for the following day off study medication (in order to assess off-treatment hemodynamics). Number and dose of intravenous vasoactive medications will be recorded daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 will be eligible for inclusion in this protocol if they satisfy the following criteria:
- •DCM with left ventricular ejection fraction (LVEF) ≤40%
- •New York Heart Association (NYHA) class III-IV symptoms
- •an indwelling PA catheter
- •and an anticipated clinical requirement for a PA catheter for at least five days.
排除标准
- •Patients will be ineligible for inclusion in this protocol if they have any of the following:
- •urgent (<6 hr) need for (or increase in) inotropic support (INTERMACS profile 1)
- •diabetes mellitus
- •known disorder of the respiratory chain or mitochondrial cardiomyopathy
- •significant hyperlipidemia with triglyceride value >300mg/dL
- •normal cardiac index (>2.5L/min/m2) on initial right heart catheterization
- •indwelling intra-aortic balloon pump
- •chronic liver disease
- •severe renal dysfunction (CKD stage IV-V) with creatinine clearance <30 mL/min/1.73m2
- •more than moderate valvular stenosis or regurgitation
- •pregnancy or breastfeeding
- •peripartum cardiomyopathy diagnosed within the past year
- •inability to provide informed consent
研究组 & 干预措施
Triheptanoin oil
The standard dose of triheptanoin oil for adults is 1-2gm/kg/24 hours. For purposes of this study, we will administer 0.25mg/kg four-times per day. The liquid study drug will be mixed into sugar-free, low fat yogurt, pudding or nutritional supplement shake, depending on patient preference.
干预措施: Triheptanoin oil (Drug)
Simple sugar
0.25mg/kg of sugar syrup will be mixed into sugar-free, low fat yogurt, pudding or nutritional supplement shake four-times per day before meals.
干预措施: Triheptanoin oil (Drug)
结局指标
主要结局
Cardiac output/index
时间窗: 6 hours
The main outcome of interest is the change in cardiac index over the first 6 hours of the study period (before initiation of any other vasoactive medications). Pre-and post-cardiac index will be compared with a paired t-test. With 10 patients per study group, we have 80% power to detect a clinically significant 20% difference (0.4L/min/m2) in cardiac index between treatment assignments. Assuming the need for a non-parametric analysis a "standard" 20% increase in sample size will need sought. This yields a final 12 patient per group (n=24 total) sample size
次要结局
- Cardiac Output/index and pulmonary capillary wedge pressure(5 days)
研究者
Aslan Turer
Assistant Professor of Medicine
University of Texas Southwestern Medical Center