CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pulmonary Capillary Wedge Pressure (PCWP) at rest
研究概览
简要总结
The purpose of this study is to evaluate pulmonary capillary wedge pressure (PCWP) and other hemodynamic measurements at rest and during exercise in healthy volunteers across the age spectrum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy volunteers are eligible to participate in this study if they are free of symptoms of exertional breathlessness or fatigue and any diagnosis of heart failure.
- •Patients will also be required to have left ventricular ejection fraction (EF) ≥ 50%.
- •Patients discovered to reduced EF or abnormal resting hemodynamics or other pathologic findings previously undiscovered will be considered screen failures and can be replaced by others to reach the goal enrollment.
- •Informed consent were obtained.
- •No history of heart failure.
- •Willing and able to undergo invasive hemodynamic exercise testing, MRI, and other study assessments.
排除标准
- •Clinically significant symptoms of exertional dyspnea or fatigue in daily life in the opinion of the investigators.
- •Any diagnosis of heart failure
- •Symptomatic coronary artery disease (e.g., patients with chronic angina)
- •Symptomatic valvular heart disease
- •Pulmonary hypertension
- •Cardiomyopathies
- •High output heart failure
- •Pericardial disease
- •Clinically significant chronic lung disease in the opinion of the investigators
- •Anemia (hemoglobin <12 gm/dL in women and <13 gm/dL in men)
- •Estimated glomerular filtration rate ≤30mL/min
- •Pregnant women
- •Any other disorders or problems that would interfere with the ability to participate safely in the study (e.g. psychiatric disorder or substance abuse)
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Healthy Volunteers
Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.
干预措施: Right Heart Catheterization with Hemodynamics and Limited Echocardiogram (Procedure)
Healthy Volunteers
Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.
干预措施: Dual X-ray absorptiometry (DEXA) scan (Procedure)
结局指标
主要结局
Pulmonary Capillary Wedge Pressure (PCWP) at rest
时间窗: Baseline
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter at rest.
Pulmonary Capillary Wedge Pressure (PCWP) during exercise
时间窗: Baseline
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
次要结局
- Visceral fat content(Baseline)
- Myocardial fat content(Baseline)
- Total plasma volume(Baseline)
- Blood glucose level(Baseline)
- Trans-cardiac uptake of free fatty acids (FFA) during exercise(Baseline)
- Trans-cardiac uptake of ketone bodies at rest(Baseline)
- Trans-cardiac uptake of free fatty acids (FFA) at rest(Baseline)
- Trans-cardiac uptake of glucose at rest(Baseline)
- Trans-cardiac uptake of glucose during exercise(Baseline)
- Trans-cardiac uptake of ketone bodies during exercise(Baseline)
- Left Atrial (LA) reservoir strain(Baseline)
- Myocardial mass(Baseline)
- Myocardial volume(Baseline)
- Blood insulin level(Baseline)
- Blood free fatty acids (FFA) level(Baseline)
- Left ventricular (LV) global longitudinal strain(Baseline)
- Right Ventricular (RV) free wall strain(Baseline)
- Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline)
- Body fat mass(Baseline)
- Total blood volume(Baseline)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic