Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05935605

Conditions

Pulmonary Hypertension

Pulmonary Vascular Disease

Left Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transthoracic Echocardiography (TTE)

Lung ultrasound

Study Details

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

Study ID

NCT05935605

Start date

Jul 20, 2023

Status verified date

Mar, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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.

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 measure

  • Peak Exercise Cardiac Output [ Time Frame: Baseline ]
  • Peak Exercise Oxygen Consumption (VO2) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Circulatory Failure Research Team

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

Barry Borlaug, MD

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Circulatory Failure Research Team

(507) 255-2200

Barry Borlaug, MD

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

Principal Investigator:

Barry Borlaug, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-05.