Clinical trial NCT05935605: Pulmonary Hypertension in Left Heart Disease
Official title: Comparison of Noninvasively-Obtained Echocardiographic Doppler Parameters With Simultaneously-Measured Invasive Hemodynamics in Patients Referred for Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Pulmonary Vascular Disease
Left Heart Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-07-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak Exercise Cardiac Output
timeFrame: Baseline
measure: Peak Exercise Oxygen Consumption (VO2)
timeFrame: Baseline
Secondary outcomes:
measure: Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE)
timeFrame: Baseline
measure: Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio
timeFrame: Baseline
measure: Extravascular Lung Fluid Content (B-line score)
timeFrame: Baseline
measure: Peripheral venous pressure
timeFrame: Baseline
measure: Right Arterial Pressure (RA) in the upright position
timeFrame: Baseline
measure: Central pressures (RA, PA, and PCWP) in the upright position
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References: