Pulmonary Hypertension in Left Heart Disease
Recruiting now
Conditions studied: Pulmonary Hypertension, Pulmonary Vascular Disease, Left Heart Disease
In brief
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.
Key facts
- Study ID
- NCT05935605
- Run by
- Mayo Clinic
- People needed
- 3000
- Starts
- 2023-07-20
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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