Pulmonary Hypertension in Left Heart Disease

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест Transthoracic 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.
• Диагностический тест Lung 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.

Первичные конечные точки

• Peak Exercise Cardiac Output [Срок оценки: Baseline]
• Peak Exercise Oxygen Consumption (VO2) [Срок оценки: Baseline]

Вторичные конечные точки (6)

• Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE) [Срок оценки: Baseline]
• Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio [Срок оценки: Baseline]
• Extravascular Lung Fluid Content (B-line score) [Срок оценки: Baseline]
• Peripheral venous pressure [Срок оценки: Baseline]
• Right Arterial Pressure (RA) in the upright position [Срок оценки: Baseline]
• Central pressures (RA, PA, and PCWP) in the upright position [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT05935605 · 17-008263 · 1R01HL162828-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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