Pulmonary Hypertension in Left Heart Disease

Last updated: February 17, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Arterial Hypertension

Scleroderma

Vascular Diseases

Treatment

Transthoracic Echocardiography (TTE)

Lung ultrasound

Clinical Study ID

NCT05935605
17-008263
1R01HL162828-01A1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients referred to the cardiac catheterization laboratory for invasive right heartcatheterization 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), andobjective 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 ofHFpEF that does not meet criteria i. or ii. but verified with NTproBNP>300pg/ml in sinus rhythm or >900 pg/ml in AF; H2FPEF score ≥6 or HFA-PEFF score≥5according 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 valvedisease (regurgitation and/or stenosis).

Exclusion

Exclusion Criteria:

  • Patient inability or unwillingness to undergo noninvasive echocardiography, or ifechocardiography would, in the opinion of the investigator, somehow compromise thequality 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

Total Participants: 3000
Treatment Group(s): 2
Primary Treatment: Transthoracic Echocardiography (TTE)
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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