Pulmonary Hypertension in Left Heart Disease

Recruiting

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

• Registration Number: NCT05935605
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-06-29
• Study First Posted: 2023-07-07
• Study Start: 2023-07-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Exercise Cardiac Output	Baseline	Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization.
Peak Exercise Oxygen Consumption (VO2)	Baseline	Peak exercise VO2 (ml/kg/min) will be measured using expired gas analysis collected during the invasive hemodynamic assessment by right heart catheterization.

Secondary Outcome Measures

Name	Time	Method
Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE)	Baseline	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.
Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio	Baseline	TAPSE/PASP ratio (mm/mmHg) will be measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization.
Peripheral venous pressure	Baseline	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)
Right Arterial Pressure (RA) in the upright position	Baseline	Right Atrial (RA) pressure will be measured during the invasive hemodynamic assessment by right heart catheterization.
Central pressures (RA, PA, and PCWP) in the upright position	Baseline	The same pressures that are measured in the supine position will be measured in the upright position in a subset of patients. These measures will be obtained at rest and during exercise (for those receiving this).
Extravascular Lung Fluid Content (B-line score)	Baseline	Extravascular Lung Fluid Content (B-line score) will be measured using lung ultrasound during the invasive hemodynamic assessment by right heart catheterization.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States