Comparing pulmonary hypertension in patients with left heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare patients with varying severity of pulmonary vascular disease by analyzing hemodynamic signatures, echocardiographic measures, and lung ultrasound results. It will also incorporate expired gas metabolic testing and blood sampling to gather comprehensive data. Patients referred for invasive right heart catheterization will be included, focusing on those with symptomatic heart failure with preserved or reduced ejection fraction, as well as symptomatic valvular heart disease. The study will utilize transthoracic echocardiography and lung ultrasound as key assessment tools.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Barry Borlaug, MD — Mayo Clinic
• Study coordinator: Circulatory Failure Research Team
• Email: Fuenffinger.Annabelle@mayo.edu
• Phone: (507) 255-2200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.