NCT07087210进行中（未招募）不适用
In Vivo Quantitative Mapping of Mitochondrial Cardiac Membrane Potential in Heart Failure
Matthieu Pelletier-Galarneau, MD MSc1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Average difference of membrane potential (ΔΨT) in sedentary adults vs subjects with Heart Failure with Preserved Ejection Fraction (HFpEF)
研究概览
简要总结
This research aims to develop a new method to measure how well mitochondria are working using a special imaging technique called PET (positron emission tomography) with a tracer called 18F-TPP+. This tracer helps us visualize and measure mitochondrial function in a non-invasive way.
详细描述
Our study has three main goals:
- Measure Mitochondrial Function in Different Groups: The investigators will compare mitochondrial function in three groups: healthy active individuals, sedentary individuals, and heart failure patients. The investigators expect to see higher mitochondrial function in active individuals and lower function in heart failure patients. The investigators will also test the consistency of our measurements.
- Correlate Mitochondrial Function with Health Indicators: The investigators will see if our mitochondrial function measurements relate to other health markers, such as exercise capacity, heart health, muscle strength, and cognitive function.
- Improve the Production of the Tracer: The investigators will refine how they make the 18F-TPP+ tracer to make it more efficient and cost-effective for widespread use in research and clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active participants:
- •≥40 years old
- •Body Mass Index <35kg/m2
- •NYHA fuctional class I
- •Engaged in aerobic exercise (running cycling or swimming) for ≥3 days per week or 5 hours per week without extensive layoff over the previous 6 months
- •Non-smoker ≥1 year
- •Fasting glycemia <6.0 mmol/L
- •HbA1c <5.7%
- •Sedentary participants:
- •≥40 years old
- •Body Mass Index <35kg/m2
- •NYHA fuctional class
- •≤1 structured physical activity per week
- •Non-smoker ≥1 year
- •Fasting glycemia <6.0 mmol/L
- •HbA1c <5.7%
- •HFpEF participants:
- •Chronic symptomatic HF and LVEF >40% within 12 months before the screening visit (regardless of the imaging modality)
- •One of the following abnormalities:
- •HF requiring hospitallization and IV diuretics within 12 months of study entry
- •NTproBNP >150 pg/ml in sinus rhythm
- •NTproBNP >450 pg/ml in chronic atrial fibrillation
排除标准
- •for all participants :
- •Infiltrative CMP (e.g., cardiac amyloidosis)
- •Hypertrophic CMP
- •Dilated CMP
- •Ischemic CMP with myocardial infarction
- •Other chronic diseases or medications that may interfere with mitochondrial function
- •Primary severe valvular disease
- •Pericardial disease
- •Defibrillator
- •Congenital heart disease
- •History of cardiac transplant
- •BMI >45 kg/m2
- •High resting blood pressure ≥150/90 mmHg
- •Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73m2
- •Iodinated contrast allergy
- •Women of child bearing potential
- •Breastfeeding
- •Inability to undergo the imaging logistics
- •Any condition that, in the opinion of the investigator, could compromise the participation in the study
结局指标
主要结局
Average difference of membrane potential (ΔΨT) in sedentary adults vs subjects with Heart Failure with Preserved Ejection Fraction (HFpEF)
时间窗: Up to 3 months
Compare membrane potential (ΔΨT) of patients suffering from Heart Failure with Preserved Ejection Fraction (HFpEF) to healthy sedentary adults matched for age and sex.
次要结局
- Average difference of membrane potential (ΔΨT) in active adults vs healthy sedentary adults(Up to 3 months)
- Correlation coefficients between membrane potential (ΔΨT) and ECV vs VO2max, grip strength, left ventricular mass, NT-pro-BNP, neurocognitive function, and NYHA functional class.(Up to 5 months)
- Coefficient of repeatability between membrane potential (ΔΨT) and ECV repeated measurements.(Up to 3 months)
研究者
Matthieu Pelletier-Galarneau, MD MSc
MD MSc
Montreal Heart Institute
研究点 (1)
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