Pulmonary Hypertension in Left Heart Disease

Mayo Clinic

Status: Enrolling

Conditions: Left Heart Disease; Pulmonary Vascular Disease; Pulmonary Hypertension

Treatments: Diagnostic Test: Transthoracic Echocardiography (TTE); Diagnostic Test: Lung ultrasound

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05935605

1R01HL162828-01A1 (U.S. NIH Grant/Contract)

17-008263

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 4 patient groups

LHD with no PH

Description:

Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Treatment:

Diagnostic Test: Lung ultrasound

Diagnostic Test: Transthoracic Echocardiography (TTE)

LHD with isolated PVH

Description:

Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure\>20 mmHg and PVR\<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Treatment:

Diagnostic Test: Lung ultrasound

Diagnostic Test: Transthoracic Echocardiography (TTE)

LHD with vasoactive PVD

Description:

Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Treatment:

Diagnostic Test: Lung ultrasound

Diagnostic Test: Transthoracic Echocardiography (TTE)

LHD with fixed PVD

Description:

Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg, PVR≥3 WU, and PVR reduction of \<20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Treatment:

Diagnostic Test: Lung ultrasound

Diagnostic Test: Transthoracic Echocardiography (TTE)