CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study

Обзор

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.

Вмешательства

• Процедура Right Heart Catheterization with Hemodynamics and Limited Echocardiogram
  Right Heart Catheterization (RHC) with Hemodynamics and Limited Echocardiogram is an invasive procedure that involves insertion of a catheter through a blood vessel in the neck, groin, or arm to the right side of the heart. Hemodynamic measurements such as the blood pressure inside the veins, heart, and arteries as well as measurements of blood flow and how much oxygen is in the blood will be completed during the catheterization procedure. It is a way to see how well the heart is working during
• Процедура Magnetic Resonance Imaging (MRI)
  MRI is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. CMR Imaging will assess myocardial structure, function, and fat content. An additional limited MRI sequence of the the abdomen and one sequence in the thigh will be used to evaluate for visceral adipose tissue (VAT) as a measurement of body composition.
• Процедура Dual X-ray absorptiometry (DEXA) scan
  A DEXA scan measures the amount of fat in the body using an x-ray that measures bone, calcium and fat.

Первичные конечные точки

• Pulmonary Capillary Wedge Pressure (PCWP) at rest [Срок оценки: Baseline]
• Pulmonary Capillary Wedge Pressure (PCWP) during exercise [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Trans-cardiac uptake of free fatty acids (FFA) at rest [Срок оценки: Baseline]
• Trans-cardiac uptake of free fatty acids (FFA) during exercise [Срок оценки: Baseline]
• Trans-cardiac uptake of glucose at rest [Срок оценки: Baseline]
• Trans-cardiac uptake of glucose during exercise [Срок оценки: Baseline]
• Trans-cardiac uptake of ketone bodies at rest [Срок оценки: Baseline]
• Trans-cardiac uptake of ketone bodies during exercise [Срок оценки: Baseline]
• Left ventricular (LV) global longitudinal strain [Срок оценки: Baseline]
• Left Atrial (LA) reservoir strain [Срок оценки: Baseline]
• Right Ventricular (RV) free wall strain [Срок оценки: Baseline]
• Myocardial mass [Срок оценки: Baseline]
• Myocardial volume [Срок оценки: Baseline]
• Myocardial fat content [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06220396 · 23-007522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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