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Observational Study of Pulmonary Hypertension in Left Heart Disease

This observational study is looking at people with pulmonary hypertension (high blood pressure in the lungs) and left heart disease. Researchers want to understand how different levels of pulmonary vascular disease (problems with blood vessels in the lungs) affect people. They will use tests like transthoracic echocardiography (an ultrasound of the heart) and lung ultrasound to gather information during routine heart catheterization procedures. They will also look at how much oxygen your body uses during exercise. You can join if you are 18 or older, are having a right heart catheterization, and have left heart disease. The study aims to enroll 3000 participants. The current recruitment status is unclear.

Study design
This is an observational study aiming to enroll 3000 participants. It compares patients with and without varying severity of pulmonary vascular disease.
What's involved
You would undergo transthoracic echocardiography and lung ultrasound during the rest and exercise phases of your clinically indicated invasive right heart catheterization.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05935605

Pulmonary Hypertension in Left Heart Disease

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~3,000 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Transthoracic Echocardiography (TTE)Lung ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak Exercise Cardiac Output
Measured over Baseline
+1 more outcome measured

Conditions

Pulmonary Hypertension
Pulmonary Vascular Disease
Left Heart Disease

Explore related trials

Heart FailurePulmonary HypertensionValvular Heart Disorder

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Barry Borlaug, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Circulatory Failure Research Team
[email protected]
(507) 255-2200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Peak Exercise Cardiac OutputBaseline

    Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization.

  • Peak Exercise Oxygen Consumption (VO2)Baseline

    Peak exercise VO2 (ml/kg/min) will be measured using expired gas analysis collected during the invasive hemodynamic assessment by right heart catheterization.