Transthoracic Echocardiography and Lung Ultrasound for Pulmonary Hypertension

Overseen By Barry Borlaug, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: PH-specific drugs

Disqualifiers: Pulmonary hypertension, Lung disease, Myocarditis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the link between left heart disease and various types of pulmonary hypertension (high blood pressure in the lungs). Researchers aim to understand the interaction between the heart and lungs by comparing patients with different heart and lung conditions using tests like echocardiograms (heart ultrasound) and lung ultrasounds. Participants should have left heart disease and experience symptoms such as shortness of breath or fatigue. This trial may help identify better ways to manage these heart-lung issues in the future. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage advancements in managing heart-lung conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using pulmonary hypertension-specific drugs. It's best to discuss your medications with the trial team.

What prior data suggests that lung ultrasound and transthoracic echocardiography are safe for assessing pulmonary vascular disease?

Previous studies have shown that lung ultrasound is a safe and risk-free method, often used to assess lung and heart health. This technique has no known side effects, making it a comfortable choice for many patients.

Research also shows that transthoracic echocardiography (TTE) is safe and effective. TTE, a common test that uses sound waves to create heart images, is non-invasive and has been widely used without reported safety issues.

Both lung ultrasound and TTE examine heart and lung conditions and are generally considered safe. Previous studies have not reported any significant safety concerns with these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand pulmonary hypertension in patients with left heart disease using advanced imaging techniques like transthoracic echocardiography and lung ultrasound. Unlike standard treatments that focus primarily on managing symptoms with medications such as diuretics or vasodilators, this study seeks to categorize patients based on specific hemodynamic profiles. By identifying whether a patient has no pulmonary hypertension, vasoactive or fixed pulmonary vascular disease, or isolated pulmonary venous hypertension, doctors can tailor treatments more precisely. This trial could lead to improved diagnostic accuracy and personalized treatment plans, potentially enhancing patient outcomes.

What evidence suggests that lung ultrasound and transthoracic echocardiography could be effective for assessing pulmonary vascular disease?

In this trial, participants will undergo both lung ultrasound and transthoracic echocardiography (TTE) to assess heart and lung health. Research has shown that lung ultrasound is a helpful tool for checking and predicting outcomes in people with heart failure. It detects high blood pressure in the lungs related to left heart problems, especially in urgent situations. TTE, on the other hand, is useful for diagnosing and assessing the severity of left heart issues. Studies indicate that it accurately estimates pressures in the heart and lungs. Both methods are non-invasive and provide important insights into heart and lung health. These tools hold promise for managing conditions related to high blood pressure in the lungs and left heart disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Barry Borlaug, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients referred to the cardiac catheterization laboratory for invasive right heart catheterization for any reason.

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%).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including echocardiographic measures, lung ultrasound, and invasive hemodynamic assessment by right heart catheterization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lung ultrasound
• Transthoracic Echocardiography (TTE)

How Is the Trial Designed?

Group I: LHD with vasoactive PVD Experimental Treatment 2 Interventions

Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Group II: LHD with no PH Experimental Treatment 2 Interventions

Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Group III: LHD with isolated PVH Experimental Treatment 2 Interventions

Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure\>20 mmHg and PVR\<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Group IV: LHD with fixed PVD Experimental Treatment 2 Interventions

Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg, PVR≥3 WU, and PVR reduction of \<20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10800768/

Correlation analysis between lung ultrasound scores and ... LUS is a potential screening tool used for the initial investigation of PH-LHD, especially in emergencies or critical care settings. Keywords: Acute heart ...

2. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.111.085761

Pulmonary Hypertension Due to Left Heart Disease Data show a high prevalence of reactive PH, where 80% to 90% of patients with HFrEF and HFpEF displayed PVR >1.7 WU (2 SDs beyond normal), and ...

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.758147/full

The Prognostic Value of Lung Ultrasound in Patients With ... Lung ultrasound (LUS) is a promising screening and prognostic tool in the heart failure population. However, more information on its value in predicting ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213177924004360

Considerations in the Diagnosis and Management of ... This paper provides an overview of the diagnostic challenges, associated comorbidities, and updated management recommendations in existing subsets of PH-LHD.

5. jhltonline.org jhltonline.org/article/S1053-2498(24)01099-4/fulltext

Ultrasound Assessment of Pulmonary Artery Stiffening ... The current study aimed to develop a non-invasive index for the diagnosis of PA stiffening using a translational ultrasound-based approach.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10711819/

Prognostic impact of lung ultrasound detected B-lines on ... Results show that LUS-BL>11 at admission are independently associated with increased CV event at 90 days after discharge in HFmrEF patients with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667100X23000610

Correlation analysis between lung ultrasound scores and ... LUS is a readily available, inexpensive, and risk-free method that moderately correlates with PASP. LUS is a potential screening tool used for the initial ...

8. mdpi.com mdpi.com/2077-0383/13/9/2460

Prognostic Significance of Lung Ultrasound for Heart ... Additionally, treatment guided by lung ultrasound (LUS) was linked to a reduced risk of Major Adverse Cardiac Events (MACEs) [58,59], and a significantly ...

9. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.943633/full

Lung ultrasound-guided treatment for heart failure The mean LVEF was 39 ± 14%, and the primary endpoint was a composite of urgent visits, hospitalization for worsening HF, and all-cause death.

10. escardio.org escardio.org/Councils/Council-for-Cardiology-Practice-(CCP)/Cardiopractice/lung-ultrasound-usefulness-in-heart-failure

Lung ultrasound usefulness in heart failure Lung ultrasound B-lines have shown to be strong prognosticators in many different settings. They predict worse outcomes, mostly in terms of ...