Pulmonary Hypertension in Left Heart Disease

Mayo Clinic3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Pulmonary Hypertension Pulmonary Vascular Disease Left Heart Disease

Interventions

Transthoracic Echocardiography (TTE)DIAGNOSTIC_TEST

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.

Lung ultrasoundDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Peak Exercise Cardiac Output

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

Time frame: Baseline

Peak Exercise Oxygen Consumption (VO2)

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

Time frame: Baseline

Secondary Outcomes

Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE)

TAPSE is measured as the displacement (in mm) of the lateral tricuspid annulus toward the apex during systole measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization.

Time frame: Baseline

Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio

TAPSE/PASP ratio (mm/mmHg) will be measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization.

Time frame: Baseline

Extravascular Lung Fluid Content (B-line score)

Extravascular Lung Fluid Content (B-line score) will be measured using lung ultrasound during the invasive hemodynamic assessment by right heart catheterization.

Time frame: Baseline

Peripheral venous pressure

Peripheral venous pressure will be measured through a standard upper extremity peripheral IV line. Peripheral venous pressure (PVP) is reported in millimeters of mercury (mmHg)

Central Contacts

Circulatory Failure Research Team

CONTACT

(507) 255-2200

Barry Borlaug, MD

CONTACT

(507) 255-4152 Borlaug.Barry@mayo.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.