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Recruiting NCT05935605

Pulmonary Hypertension in Left Heart Disease

— Observational Pulmonary Hypertension Pulmonary Vascular Disease Left Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transthoracic Echocardiography (TTE), Lung ultrasound.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension, Pulmonary Vascular Disease, Left Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Diagnostic test 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.
  • Diagnostic test 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.

Primary outcome measures

  • Peak Exercise Cardiac Output [Time frame: Baseline]
  • Peak Exercise Oxygen Consumption (VO2) [Time frame: Baseline]
Secondary outcome measures (6)
  • Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE) [Time frame: Baseline]
  • Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio [Time frame: Baseline]
  • Extravascular Lung Fluid Content (B-line score) [Time frame: Baseline]
  • Peripheral venous pressure [Time frame: Baseline]
  • Right Arterial Pressure (RA) in the upright position [Time frame: Baseline]
  • Central pressures (RA, PA, and PCWP) in the upright position [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗