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Point-of-care Ultrasound for Left Ventricular Hypertrophy

N/A

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Two blood pressure measurements greater than 140 mmHg systolic and greater than 90 mmHg diastolic on two separate vital sign checks obtained as part of routine ED care

Be older than 18 years old

Must not have

Subjects in extremis or lacking capacity to consent

History of/known left ventricular hypertrophy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the end of the study, approximately 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to evaluate the effectiveness of using ultrasound to diagnose LVH in the ED and reduce disparities in diagnosis and treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic procedures and customized instructions rather than medication, there are no direct side effects from interventions like drugs. However, participants may experience anxiety or discomfort during POCUS.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with thickening of the heart's left ventricle.

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I have been treated for high blood pressure in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the end of the study, approximately 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the end of the study, approximately 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the end of the study, approximately 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prevalence of LVH by POCUS

Secondary study objectives

Prevalence of LVH stratified by race, ethnicity and gender

Rate of successful follow-up in group of subjects with LVH on POCUS

Rate of treatment in group of subjects with LVH on POCUS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Feasibility: Disclosure, customized discharge and expedited referral instructionsExperimental Treatment1 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)

0 / 4Eligibility criteria met