RecruitingNCT05935605

Pulmonary Hypertension in Left Heart Disease

Comparison of Noninvasively-Obtained Echocardiographic Doppler Parameters With Simultaneously-Measured Invasive Hemodynamics in Patients Referred for Right Heart Catheterization

Sponsor

Mayo Clinic

Enrollment

3,000 participants

Start Date

Jul 20, 2023

Study Type

OBSERVATIONAL

Conditions

Pulmonary Hypertension Pulmonary Vascular Disease Left Heart Disease

Summary

The goal is to compare patients with and without varying severity of pulmonary vascular disease based upon hemodynamic signatures, echocardiographic measures, and lung ultrasound, in tandem with expired gas metabolic testing and blood sampling.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria17

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

Interventions

DIAGNOSTIC_TESTTransthoracic Echocardiography (TTE)

Transthoracic echocardiography using ultrasound waves will be conducted during the rest and exercise phases of the clinically indicated invasive hemodynamic assessment by right heart catheterization to gather additional measurements of right ventricular function.

DIAGNOSTIC_TESTLung ultrasound

A lung ultrasound, which uses sound waves to produce images of the lungs, will be used to assess extravascular lung fluid during the rest and exercise phases of the clinically indicated invasive hemodynamic assessment by right heart catheterization.