NCT06220396

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
32mo left

Started Jan 2026

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

December 28, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

December 28, 2023

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pulmonary Capillary Wedge Pressure (PCWP) at rest

    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.

    Baseline

  • Pulmonary Capillary Wedge Pressure (PCWP) during exercise

    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.

    Baseline

Secondary Outcomes (20)

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

    Baseline

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

    Baseline

  • Trans-cardiac uptake of glucose at rest

    Baseline

  • Trans-cardiac uptake of glucose during exercise

    Baseline

  • Trans-cardiac uptake of ketone bodies at rest

    Baseline

  • +15 more secondary outcomes

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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

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

Interventions

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

Healthy Volunteers

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.

Also known as: CMR Imaging
Healthy Volunteers

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

Healthy Volunteers

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

HemodynamicsMagnetic Resonance SpectroscopyAbsorptiometry, Photon

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometry

Study Officials

  • Barry Borlaug, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barry Borlaug, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 23, 2024

Study Start

January 22, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations