Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06220396

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

Right Heart Catheterization with Hemodynamics and Limited Echocardiogram

Magnetic Resonance Imaging (MRI)

Dual X-ray absorptiometry (DEXA) scan

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT06220396

Start date

Jan 22, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brendon Urena

507-538-8305Urena.brendon@mayo.edu

Barry Borlaug, MD

Borlaug.Barry@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Dr. Borlaug's Research Team

(507) 255-2200

Barry Borlaug, MD

(507) 255-1051Borlaug.Barry@mayo.edu

Principal Investigator:

Barry Borlaug, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-14.