Comparing pulmonary hypertension in patients with left heart disease
Comparison of Noninvasively-Obtained Echocardiographic Doppler Parameters With Simultaneously-Measured Invasive Hemodynamics in Patients Referred for Right Heart Catheterization
Mayo Clinic · NCT05935605
This study is trying to understand how pulmonary hypertension affects patients with heart disease by looking at different tests and measurements to see how their condition varies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05935605 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with left heart disease who are being referred for cardiac catheterization.
Not a fit: Patients without left heart disease or those not undergoing cardiac catheterization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of pulmonary hypertension in left heart disease, leading to improved diagnosis and treatment strategies for affected patients.
How similar studies have performed: Other studies have shown success in using echocardiographic measures and metabolic testing to assess pulmonary hypertension, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Hypertension, Pulmonary Vascular Disease, Left Heart Disease