跳至主要内容
临床试验/NCT05460572
NCT05460572Unknown不适用

Cardiac Metabolic Profiling in the Fed State

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Quantitative analysis of cardiac uptake and release of metabolites in the fed state

研究概览

简要总结

This is a non-randomized interventional prospective study, aiming to provide insight into cardiac substrate utilization in the fed state. Patients will participate during an elective PVI procedure which would have taken place regardless of the current study. During this study, study subjects will receive peripheral parenteral nutrition (PPN) through an intravenous (iv) line. During the procedure, blood samples will be drawn from the catheters which will be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

详细描述

The heart requires tremendous amounts of energy to sustain its continuous mechanical work. The heart can utilize various metabolic substrates to generate energy, including carbohydrates, lipids, amino acids and ketone bodies. However, most research on cardiac fuel use has been done in rodents and surprisingly little is known about cardiac fuel use in patients with heart disease. Prior experimental studies showed that carbohydrates are important fuels for cardiac energy production. In contrast, a recent study in patients with heart disease showed that the heart only utilizes little amounts of carbohydrates. This study was however, performed in fasting subjects, which could have an important effect on substrate preference. The primary aim of this non-randomized interventional prospective study is to provide insight into cardiac substrate utilization in the fed state. Patients will participate during an elective PVI procedure which would have taken place regardless of the current study. During this study they will receive peripheral parenteral nutrition (PPN) through an intravenous (iv) line. Blood samples will be drawn with the catheters which will already be in situ for the purpose of the elective PVI procedure. Cardiac arteriovenous (A-V) gradients of metabolites will be measured, reflecting cardiac uptake and release of metabolites in the fed state.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Undergoing elective PVI procedure
  • Adult age (≥ 18 years)
  • Have given verbal and written informed consent

排除标准

  • Chronic renal disease with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
  • Chronic liver disease and/or severe liver dysfunction with ASAT and/or ALAT > 3x the upper limit of normal (ULN)
  • Pregnancy or breastfeeding
  • Insulin dependent diabetics
  • Congenital metabolic disease
  • Weight below 40 kg
  • Inability to understand and read Dutch or English
  • Known allergy or hypersensitivity to any of the non-investigational products in the study protocol
  • Any other clinical condition that would jeopardize patient's safety while participating in this trial or may prevent the patient from adhering to the trial protocol.

结局指标

主要结局

Quantitative analysis of cardiac uptake and release of metabolites in the fed state

时间窗: Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.

Cardiac fuel use will be mapped by metabolomics on blood from the left atrium, the coronary sinus and the right atrium during PVI procedure. By comparing the concentrations of metabolites in the blood from different anatomical locations, cardiac uptake or release of energy substrates will be determined.

次要结局

  • Quantitative analysis of uptake and release of metabolites in the fed state in the lower extremity(Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.)
  • Differences in cardiac uptake and release of metabolites between heart failure patients with reduced, mid-range and preserved ejection fraction and patients without HF(Peripheral Parental Nutrition will start before start of the PVI procedure. Sixty minutes after start of peripheral parental nutrition, blood sampling will be performed.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Cardiac Metabolic Profiling in the Fed State | 临床试验