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NCT Number: NCT06220396

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

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.

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Key information

Conditions

Healthy

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Barry Borlaug, MD

CONTACT

[email protected]

(507) 255-1051

Barry Borlaug, MD

PRINCIPAL_INVESTIGATOR

Dr. Borlaug's Research Team

CONTACT

(507) 255-2200

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Right Heart Catheterization with Hemodynamics and Limited Echocardiogram

Procedure

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 your procedure. During the RHC procedure a limited echocardiogram, using ultrasound waves, will be collected to evaluate the structure and function of the heart.

All measurements will be conducted at rest and during exercise using a supine cycle ergometer

Magnetic Resonance Imaging (MRI)

Procedure

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.

Other names: CMR Imaging

Dual X-ray absorptiometry (DEXA) scan

Procedure

A DEXA scan measures the amount of fat in the body using an x-ray that measures bone, calcium and fat.

Primary outcomes

  1. Pulmonary Capillary Wedge Pressure (PCWP) at rest

    Time frame: 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.

  2. Pulmonary Capillary Wedge Pressure (PCWP) during exercise

    Time frame: 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.

Secondary outcomes

  1. Trans-cardiac uptake of free fatty acids (FFA) at rest

    Time frame: Baseline

    Trans-cardiac uptake of FFA will be measured using arterial and coronary sinus blood samples collected at rest during cardiac catheterization procedure.

  2. Trans-cardiac uptake of free fatty acids (FFA) during exercise

    Time frame: Baseline

    Trans-cardiac uptake of FFA will be measured using arterial and coronary sinus blood samples collected during the exercise portion of the cardiac catheterization procedure.

  3. Trans-cardiac uptake of glucose at rest

    Time frame: Baseline

    Trans-cardiac uptake of glucose will be measured using arterial and coronary sinus blood samples collected at rest during the cardiac catheterization procedure.

  4. Trans-cardiac uptake of glucose during exercise

    Time frame: Baseline

    Trans-cardiac uptake of glucose will be measured using arterial and coronary sinus blood samples collected during the exercise portion of the cardiac catheterization procedure.

  5. Trans-cardiac uptake of ketone bodies at rest

    Time frame: Baseline

    Trans-cardiac uptake of ketone bodies will be measured using arterial and coronary sinus blood samples collected at rest during the cardiac catheterization procedure.

  6. Trans-cardiac uptake of ketone bodies during exercise

    Time frame: Baseline

    Trans-cardiac uptake of ketone bodies will be measured using arterial and coronary sinus blood samples collected during the exercise portion of the cardiac catheterization procedure.

  7. Left ventricular (LV) global longitudinal strain

    Time frame: Baseline

    LV global longitudinal strain will be assessed by echocardiography conducted during the cardiac catheterization procedure

  8. Left Atrial (LA) reservoir strain

    Time frame: Baseline

    LA reservoir strain will be assessed by echocardiography conducted during the cardiac catheterization procedure

  9. Right Ventricular (RV) free wall strain

    Time frame: Baseline

    RV free wall strain will be assessed by echocardiography conducted during the cardiac catheterization procedure

  10. Myocardial mass

    Time frame: Baseline

    Myocardial mass will be measured by CMR imaging.

  11. Myocardial volume

    Time frame: Baseline

    Myocardial volume will be measured by CMR imaging.

  12. Myocardial fat content

    Time frame: Baseline

    Myocardial fat content will be measured by CMR imaging.

  13. Body fat mass

    Time frame: Baseline

    Body fat mass will be measured using dual X-ray absorptiometry (DEXA)

  14. Visceral fat content

    Time frame: Baseline

    Visceral fat content will be measured using limited abdominal MRI

  15. Total blood volume

    Time frame: Baseline

    Total blood volume will be assessed by using the radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY).

  16. Total plasma volume

    Time frame: Baseline

    Total plasma volume will be assessed by using the radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique (BVA-100 Blood Volume Analyzer, Daxor Corp, NY).

  17. Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: Baseline

    KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status.

  18. Blood glucose level

    Time frame: Baseline

    Blood glucose level will be measured using oral glucose tolerance testing

  19. Blood insulin level

    Time frame: Baseline

    Blood insulin level will be measured using oral glucose tolerance testing

  20. Blood free fatty acids (FFA) level

    Time frame: Baseline

    Blood FFA level will be measured using oral glucose tolerance testing

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa Ploof

CONTACT

[email protected]

507-255-0463

Barry Borlaug, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: CAMERA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 23, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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