Point-of-care Ultrasound for Left Ventricular Hypertrophy

Overseen By Cristiana Baloescu, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Hypertension treatment, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 3

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the prevalence of a heart condition called left ventricular hypertrophy (LVH) in individuals visiting the Emergency Department (ED) with asymptomatic high blood pressure. It will also assess whether informing patients about their condition and providing special follow-up instructions improves their care. The trial involves patients with high blood pressure readings who have not recently received treatment for hypertension and are unaware of having LVH. Participants will receive customized discharge instructions and a fast-track referral to a doctor. As an unphased study, this trial offers participants the opportunity to contribute to important research that could enhance care for others with similar conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are actively being treated for high blood pressure or have active heart disease, you may not be eligible to participate.

What prior data suggests that this protocol is safe?

Research has shown that providing patients with personalized instructions upon hospital discharge and expediting their follow-up appointments is safe. This approach does not involve new medications or medical procedures. Instead, it emphasizes clear communication and ongoing care, aiding patients in better managing their health. Reports of negative effects from these instructions are absent, indicating they are well-received and pose minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method for managing Left Ventricular Hypertrophy (LVH) using point-of-care ultrasound (POCUS) to guide customized discharge and expedited referral instructions. Unlike the standard practice, which often relies on routine echocardiograms and delayed follow-ups, this approach aims to streamline the patient care process. By quickly identifying LVH with POCUS and providing tailored instructions and faster referrals, the trial could lead to earlier intervention and potentially better outcomes for patients. This innovative strategy emphasizes personalized care and could revolutionize how LVH is managed by enhancing coordination between emergency and primary care services.

What evidence suggests that this protocol is effective for left ventricular hypertrophy?

Research has shown that an enlarged heart muscle, known as left ventricular hypertrophy (LVH), often links to long-term high blood pressure. Early detection and management of this condition can improve heart health. One study suggested that using point-of-care ultrasound (POCUS) to tailor treatments may help control blood pressure more effectively. Another study emphasized the importance of early and accurate detection of LVH for better health outcomes. In this trial, participants with LVH detected on POCUS will receive personalized discharge instructions and expedited referral, which may help patients receive timely treatment, improve heart function, and reduce the risks associated with untreated LVH. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Emergency Department patients with high blood pressure readings (over 140/90 mmHg) on two separate checks, who haven't been treated for hypertension or known heart enlargement in the last year and aren't currently under a cardiologist's care. It excludes those too ill to consent, admitted to the hospital, or suspected of having a hypertensive emergency.

Inclusion Criteria

My blood pressure was over 140/90 mmHg in two separate checks.

Exclusion Criteria

Admission to the hospital

I am unable to give consent due to my severe health condition.

The doctor at the emergency room thinks you might have a serious problem with high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

POCUS Assessment

Participants undergo POCUS to assess for left ventricular hypertrophy (LVH)

Day 1

1 visit (in-person)

Intervention

Participants with LVH receive disclosure, counseling, and expedited referral

1 day

1 visit (in-person)

Follow-up

Participants are monitored for follow-up and treatment rates post-intervention

3 months

1-2 visits (virtual or in-person)

Data Collection for AI Development

Creation of a database of annotated clips for AI algorithm development

Concurrent with other phases

What Are the Treatments Tested in This Trial?

Interventions

• Customized discharge and expedited referral instructions

Trial Overview

The study aims to identify undiagnosed heart enlargement due to high blood pressure using point-of-care ultrasound (POCUS). Participants will receive education about their condition and expedited referrals for follow-up care. The impact on treatment rates after three months is being measured.

How Is the Trial Designed?

Group I: Feasibility: Disclosure, customized discharge and expedited referral instructions Experimental Treatment 1 Intervention

Participants enrolled in the Aim 1 cohort with LVH on POCUS will receive the study intervention consisting of disclosure, counseling with set discharge instructions and expedited referral (communication to existing primary care physician OR referral to follow-up clinic if no existing primary care)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Robert E. Leet and Clara Guthrie Patterson Trust

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study of 33,681 heart failure patients across 259 hospitals, only 54% received the full set of discharge instructions and education recommended by guidelines, indicating a significant gap in patient education.

The delivery of these instructions was more likely among patients receiving performance improvement tools, suggesting that enhancing these tools could improve the consistency of patient education and potentially lead to better postdischarge outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of delivery of hospital-based heart failure patient education: a report from OPTIMIZE-HF. Albert, NM., Fonarow, GC., Abraham, WT., et al.[2022]

A study involving 100 hypertensive patients showed that hand-held cardiac ultrasound (HCU) is effective in detecting left ventricular (LV) hypertrophy and concentric LV geometry, with results closely matching those obtained from standard echocardiography (SE).

The correlation between measurements of LV mass and relative wall thickness from HCU and SE was excellent, indicating that HCU can be a reliable tool for immediate assessment of cardiac health in hypertensive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care screening for left ventricular hypertrophy and concentric geometry using hand-held cardiac ultrasound in hypertensive patients. Stoica, R., Heller, EN., Bella, JN.[2021]

In a study of 30 patients with untreated hypertension, repeated echocardiographic measurements significantly reduced the risk of misclassifying left ventricular mass (LVM), lowering misclassification rates from 20% to 6% with six measurements.

Despite the benefits of repeated measurements, individuals with LVM values close to the threshold of 130 g/m² still faced a high misclassification risk of 20%, highlighting the need for careful assessment in this range.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Echocardiography of left ventricular mass in patients with essential hypertension]. Christensen, KL., Fenger-Grøn, M., Buus, NH.[2016]

In a study of 2,498 acute myocardial infarction patients, those who adhered very carefully to discharge instructions, particularly regarding medication, reported significantly less angina one year later compared to those with poor adherence, indicating that following discharge instructions can improve health outcomes.

Despite high adherence to medication instructions (94% reported very careful adherence), there was no clear link between overall risk factor management behaviors and quality of life, physical functioning, rehospitalization, or mortality, suggesting that while adherence is important, other factors may also influence these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factor management after myocardial infarction: reported adherence and outcomes. Decker, C., Ahmad, H., Moreng, KL., et al.[2009]

A quality improvement project at a hospital successfully reduced the 30-day readmission rate for congestive heart failure (CHF) patients from 28% to 14% by enhancing post-discharge follow-up care.

The study showed that scheduling follow-up appointments within two weeks of discharge significantly improved attendance rates, with 58% of patients having appointments compared to only 30% the previous year, highlighting the importance of patient education and care transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing All-cause 30-day Hospital Readmissions for Patients Presenting with Acute Heart Failure Exacerbations: A Quality Improvement Initiative. Nair, R., Lak, H., Hasan, S., et al.[2020]

Heart failure (HF) leads to significant healthcare costs and patient burden, prompting a focus on reducing hospital readmissions through improved care delivery systems.

The post discharge clinic visit (PDV) is crucial for enhancing patient care by coordinating multi-disciplinary services and addressing any gaps in evidence-based treatment after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Blueprint for the Post Discharge Clinic Visit after an Admission for Heart Failure. Soufer, A., Riello, RJ., Desai, NR., et al.[2018]

Primary care physicians (PCPs) can feasibly use a pocket-sized ultrasound (pUS) device to measure left ventricular mass index (LVMI) after a brief training session, indicating potential for improved screening for left ventricular hypertrophy (LVH) in primary care settings.

However, the study found that PCPs had low sensitivity (70%) and specificity (76%) in detecting LVH, suggesting that while the method is promising, further training and experience are needed to enhance accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Primary Care Physicians' Use of a Pocket Ultrasound Device to Measure Left Ventricular Mass in Patients with Hypertension. Bornemann, P., Johnson, J., Tiglao, S., et al.[2016]

In a study of 250 patients with mild hypertension, echocardiography (ECHO) revealed that 32% had left ventricular hypertrophy (LVH), which is significantly higher than the 9% detected by electrocardiography (ECG).

The detection of LVH through ECHO led to a notable reclassification of cardiovascular risk, with 40% of initially medium-risk patients being upgraded to high-risk status, highlighting ECHO's potential to enhance risk stratification in hypertensive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of left ventricular hypertrophy in patients with mild hypertension in primary care: impact of echocardiography on cardiovascular risk stratification. Martinez, MA., Sancho, T., Armada, E., et al.[2019]

A new clinical scoring system was developed and validated to identify patients with cardiovascular diseases who are likely to have left ventricular hypertrophy (LVH), based on data from 267 patients with angina and 227 patients with peripheral arterial disease.

The scoring system includes six independent predictors, such as age, body mass index, and history of hypertension, and was found to be strongly associated with the presence of LVH, helping to prioritize echocardiographic screenings for those at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a clinical score to identify echocardiographic left ventricular hypertrophy in patients with cardiovascular disease. Ang, DS., Fahey, TP., Wright, GA., et al.[2016]

This pilot trial will assess the feasibility of using audio-recorded discharge instructions for cardiology inpatients, involving 50 participants randomized to either usual care or the intervention, which includes audio recordings.

The study aims to evaluate the impact of these recordings on patient understanding, self-management, and adherence to care plans, with outcomes measured immediately after discharge and one week later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart sounds: a pilot randomised trial to determine the feasibility and acceptability of audio recordings to improve discharge communication for cardiology inpatients protocol. Schott, SL., Dannenberg, MD., Dodge, SE., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05730309?tab=table

Point-of-care Ultrasound and Treatment Disparities for Left ...

This study will lay the groundwork for future research to evaluate the impact of interventions informed by LVH assessment by POCUS on hypertension control, ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.121.023647

Implication of Different ECG Left Ventricular Hypertrophy in ...

We investigated the prevalence of ECG LVH according to different criteria and its prognostic impact on clinical outcomes after transcatheter aortic valve ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12461611/

Demographic-Based Personalized Left Ventricular ...

Current diagnosis emphasizes the detection of left ventricular hypertrophy (LVH) using a fixed threshold of ≥15-mm maximum wall thickness (MWT).

4.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.17515

Persistent Hypertension and Left Ventricular Hypertrophy ...

The purpose of this study was to describe procedural outcomes, hemodynamic improvement, regression of left ventricular (LV) mass hypertrophy ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865425000961

Patient-centered medical tools for sustained motivation in ...

This study aimed to develop and evaluate an exercise-support program that integrates wearable devices to enhance rehabilitation outcomes in patients with heart ...

6.

withpower.com

withpower.com/trial/phase-hypertrophy-left-ventricular-2-2023-6b6c2

Point-of-care Ultrasound for Left Ventricular Hypertrophy

This suggests that customized discharge and expedited referral instructions may help patients better manage their condition and reduce the need for ...

7.

clinicaltrial.be

clinicaltrial.be/en/details/192034?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Point-of-care Ultrasound and Treatment Disparities for Le...

Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy ... Customized discharge and expedited referral instructions.

8.

ctv.veeva.com

ctv.veeva.com/study/point-of-care-ultrasound-and-treatment-disparities-for-left-ventricular-hypertrophy

Point-of-care Ultrasound and Treatment Disparities for Left ...

Left Ventricular Hypertrophy. Treatments. Behavioral: Customized discharge and expedited referral instructions. Study type. Interventional.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12411906/

Point-of-care ultrasound can make the difference in patients ...

POCUS findings were categorized into four outcomes: inconclusive, no alterations, minor alterations, and major alterations (Fig. 1). HF staging was determined ...