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

NCT ID: NCT06220396

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Right Heart Catheterization with Hemodynamics and Limited Echocardiogram

Intervention Type 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)

Intervention Type 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.

Dual X-ray absorptiometry (DEXA) scan

Intervention Type PROCEDURE

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

Interventions

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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 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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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CMR Imaging

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Barry Borlaug

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry Borlaug, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alyssa Ploof

Role: CONTACT

507-255-0463

Barry Borlaug, MD

Role: CONTACT

Facility Contacts

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Dr. Borlaug's Research Team

Role: primary

(507) 255-2200

Barry Borlaug, MD

Role: backup

(507) 255-1051

Other Identifiers

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23-007522

Identifier Type: -

Identifier Source: org_study_id

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