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NCT Number: NCT05935605

Pulmonary Hypertension in Left Heart Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Barry Borlaug, MD

CONTACT

[email protected]

(507) 255-4152

Barry Borlaug, MD

PRINCIPAL_INVESTIGATOR

Circulatory Failure Research Team

CONTACT

(507) 255-2200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Peak Exercise Cardiac Output

    Time frame: Baseline

    Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization.

  2. Peak Exercise Oxygen Consumption (VO2)

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: Baseline

    TAPSE/PASP ratio (mm/mmHg) will be measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization.

  3. Extravascular Lung Fluid Content (B-line score)

    Time frame: Baseline

    Extravascular Lung Fluid Content (B-line score) will be measured using lung ultrasound during the invasive hemodynamic assessment by right heart catheterization.

  4. Peripheral venous pressure

    Time frame: 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)

  5. Right Arterial Pressure (RA) in the upright position

    Time frame: Baseline

    Right Atrial (RA) pressure will be measured during the invasive hemodynamic assessment by right heart catheterization.

  6. Central pressures (RA, PA, and PCWP) in the upright position

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Barry Borlaug, MD

CONTACT

[email protected]

(507) 255-4152

Circulatory Failure Research Team

CONTACT

[email protected]

(507) 255-2200

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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