Can a simple ultrasound replace a heart catheter? 3000-Person study aims to find out
NCT ID NCT05935605
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares noninvasive heart ultrasound (echocardiogram) with the standard invasive right heart catheterization in 3000 people referred for catheterization. The goal is to see if ultrasound can accurately measure heart function and blood flow during exercise. Participants will undergo both tests at the same time, along with breathing tests and blood draws.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with known or suspected Left Heart Disease (LHD) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons at Mayo Clinic in Rochester, MN will be identified and approached for participation.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients referred to the cardiac catheterization laboratory for invasive right heart catheterization for any reason. * Left Heart Disease, defined as one (or more) of the following: * Symptomatic HFpEF, defined by signs and symptoms of HF (dyspnea, fatigue), normal left ventricular (LV) EF (≥50% within 12 months of enrollment), and objective evidence of HF fulfilling at least one of the following criteria: Prior hospitalization for decompensated HF treated with intravenous diuretics; Invasively verified HFpEF defined by pulmonary capillary wedge pressure (PCWP) of ≥15 mmHg at rest and/or ≥25 mmHg during exercise; Clinical diagnosis of HFpEF that does not meet criteria i. or ii. but verified with NTproBNP\>300 pg/ml in sinus rhythm or \>900 pg/ml in AF; H2FPEF score ≥6 or HFA-PEFF score≥5 according to current guidelines. * Symptomatic HFrEF, defined by defined by signs and symptoms of HF (dyspnea, fatigue) and reduced EF (\<50%). * Symptomatic valvular heart disease (VHD), defined by signs and symptoms of HF (dyspnea, fatigue) in tandem with clinically significant aortic or mitral valve disease (regurgitation and/or stenosis). Exclusion Criteria: * Patient inability or unwillingness to undergo noninvasive echocardiography, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case. * WSPH Group 1 Pulmonary hypertension or PH (Pulmonary arterial hypertension; including congenital heart disease) * Group 3 PH (Hypoxia/Lung disease-related PH) * Group 4 PH (Thromboembolic PH) * Group 5 PH (Miscellaneous) * Clinically significant parenchymal lung disease, hypoxemia, or lung infection * Amyloid/infiltrative cardiomyopathy * Acute Myocarditis * Acute coronary syndrome or revascularization within 90 days * Use of PH-specific drugs * Constrictive pericarditis * High output heart failure * HF hospitalization within the preceding 30 days * Severe or greater aortic (AVA \< 1.0 cm2, Mean Gradient \> 40 mmHg) or severe mitral (MVA \< 1.0 cm) stenosis * Inability or unwillingness to exercise * Inadequate echocardiographic imaging windows * Inability or unwillingness to cooperate with breath holding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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