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NCT05935605Recruiting

Pulmonary Hypertension in Left Heart Disease

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

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
29 Jun 2023
Start date
20 Jul 2023
Primary completion date
May 2028
Lead sponsor
Mayo Clinic
NCT number
NCT05935605

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 20 Jul 2023 to the primary completion date, May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of PH-specific drugs

Other illness

  • WSPH Group 1 Pulmonary hypertension or PH (Pulmonary arterial hypertension; including congenital heart disease)
  • Group 3 PH (Hypoxia/Lung disease-related PH)
  • Clinically significant parenchymal lung disease, hypoxemia, or lung infection
  • Acute coronary syndrome or revascularization within 90 days
  • High output heart failure

Other

  • 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.
  • Group 4 PH (Thromboembolic PH)
  • Group 5 PH (Miscellaneous)
  • Amyloid/infiltrative cardiomyopathy
  • Acute Myocarditis
  • Constrictive pericarditis
  • 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

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.