No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
3,000 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for people with heart disease to compare their condition with varying levels of lung blood flow issues. Participants will undergo heart tests, lung scans, and blood samples.
I have been diagnosed with heart failure with preserved EF.
I have been diagnosed with heart failure with reduced EF.
I have been diagnosed with symptomatic valvular heart disease.
You may not be able to join if
I cannot have heart ultrasound tests.
I have certain types of pulmonary hypertension.
I have significant lung disease or infection.
I have had a heart attack or heart procedure in the last 90 days.
I have had heart failure hospitalization in the last 30 days.
I cannot exercise or cooperate with tests.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 ven…
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
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