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

Mayo Clinic

Status: Enrolling

Conditions: Healthy

Treatments: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Dual X-ray absorptiometry (DEXA) scan; Procedure: Right Heart Catheterization with Hemodynamics and Limited Echocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT06220396

23-007522

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.

Treatment:

Procedure: Right Heart Catheterization with Hemodynamics and Limited Echocardiogram

Procedure: Dual X-ray absorptiometry (DEXA) scan

Procedure: Magnetic Resonance Imaging (MRI)