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

Trial Summary

What is the purpose of this trial?

The objective of the proposed project is to quantify the prevalence and disparities of undiagnosed left ventricular hypertrophy (LVH) in Emergency Department (ED) patients with persistently elevated asymptomatic BP, and to measure the effect of disclosure, education, and expedited referral on 3-month outpatient follow-up and treatment rates for ED patients with newly diagnosed LVH by POCUS. Additionally, investigators will create a database of annotated clips for future development of a machine learning algorithm for LVH detection on POCUS.

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 data supports the effectiveness of the treatment for Point-of-care Ultrasound for Left Ventricular Hypertrophy?

Research shows that providing clear discharge instructions and ensuring follow-up appointments can significantly reduce hospital readmissions for heart failure patients. This suggests that customized discharge and expedited referral instructions may help patients better manage their condition and reduce the need for rehospitalization. ^{1 2 3 4 5}

How does point-of-care ultrasound differ from other treatments for left ventricular hypertrophy?

Point-of-care ultrasound is unique because it allows primary care physicians to quickly and accurately measure the heart's left ventricle using a small, portable device, which can improve the detection of left ventricular hypertrophy compared to traditional methods like electrocardiography that have lower sensitivity. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Risk factor management after myocardial infarction: reported adherence and outcomes. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

A Blueprint for the Post Discharge Clinic Visit after an Admission for Heart Failure. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of delivery of hospital-based heart failure patient education: a report from OPTIMIZE-HF. [2022]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Reducing All-cause 30-day Hospital Readmissions for Patients Presenting with Acute Heart Failure Exacerbations: A Quality Improvement Initiative. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Development and validation of a clinical score to identify echocardiographic left ventricular hypertrophy in patients with cardiovascular disease. [2016]

7. United States 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. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Point-of-care screening for left ventricular hypertrophy and concentric geometry using hand-held cardiac ultrasound in hypertensive patients. [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

[Echocardiography of left ventricular mass in patients with essential hypertension]. [2016]

10. United States 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. [2019]