Pulmonary Hypertension in Left Heart Disease

NCT05935605 | Recruiting

• 2 other identifiers: 17-0082631R01HL162828-01A1
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Pulmonary Vascular Disease; Left Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (6)

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

  Baseline

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

  Baseline

• Extravascular Lung Fluid Content (B-line score)

  Baseline

• Peripheral venous pressure

  Baseline

• Right Arterial Pressure (RA) in the upright position

  Baseline

Study Arms (4)

LHD with no PH

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.

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

LHD with isolated PVH

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.

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

LHD with vasoactive PVD

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.

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

LHD with fixed PVD

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.

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

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.

LHD with fixed PVD; LHD with isolated PVH; LHD with no PH; LHD with vasoactive PVD

Lung ultrasound DIAGNOSTIC_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.

LHD with fixed PVD; LHD with isolated PVH; LHD with no PH; LHD with vasoactive PVD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected Left Heart Disease (LHD) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons at Mayo Clinic in Rochester, MN will be identified and approached for participation.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples from the pulmonary artery and systemic artery will be collected at rest \& during exercise portion of the cardiac catheterization procedure in EDTA tubes \& stored for future discovery-based analyses.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Barry Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Circulatory Failure Research Team

CONTACT

(507) 255-2200; Fuenffinger.Annabelle@mayo.edu

Barry Borlaug, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)