NCT05935605 Pulmonary Hypertension in Left Heart Disease
| NCT ID | NCT05935605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Pulmonary Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-07-20 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Barry Borlaug, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05935605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05935605 currently recruiting?
Yes, NCT05935605 is actively recruiting participants. Contact the research team at Fuenffinger.Annabelle@mayo.edu for enrollment information.
Where is the NCT05935605 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05935605 clinical trial?
NCT05935605 is sponsored by Mayo Clinic. The principal investigator is Barry Borlaug, MD at Mayo Clinic. The trial plans to enroll 3,000 participants.