Skip to main content
OpenTrials
Completed

NCT Number: NCT05730309

Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Left Ventricular Hypertrophy Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

About this study

The rationale for the proposed project is that, through bedside LVH detection, ED POCUS can be leveraged to identify those high-risk patients with asymptomatic hypertension (HTN) and improve disease prevention equity, while also ultimately decrease cardiovascular disease burden. The objective of the proposed project is to evaluate the feasibility and impact of LVH determination by POCUS on ED patients with elevated BP, and to quantify disparities in diagnosis and treatment.

This study has 3 Aims:

Aim 1: To quantify the prevalence and disparities of undiagnosed LVH in ED patients with persistently elevated asymptomatic BP. The investigators will enroll a prospective cohort of ED patients with BP > 140/90mmHg on two measurements who will receive POCUS to assess for LVH. The investigators hypothesize an overall LVH prevalence of at least 30%.

Aim 2: 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. In a single arm feasibility clinical trial, subjects 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 a follow-up clinic if no existing primary care). The investigators hypothesize a 50% follow-up rate and a 40% treatment rate.

Aim 3: To create a database of annotated clips for development of an artificial intelligence (AI) algorithm for LVH detection on POCUS. A collection of annotated clips would support subsequent training, validation, and eventual integration into POCUS technology to facilitate larger scale screening and referral efforts.

Aim 1 will have a prospective observational study design. Aim 2 will occur sequentially based on results of POCUS performed as part of Aim 1. Aim 3 will follow a repository creation protocol utilizing the ultrasound clips obtained during Aim 1.

This study will lay the groundwork for future research to evaluate the impact of interventions informed by LVH assessment by POCUS on hypertension control, referral, and cardiovascular outcomes, as well as effectiveness of implementation strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Subjects in extremis or lacking capacity to consent
  • Active treatment of hypertension within the last year
  • History of/known left ventricular hypertrophy
  • Active cardiac disease under the care of a cardiologist within last year
  • Suspicion for hypertensive emergency by treating ED physician
  • Admission to the hospital

Treatment and study plan

Customized discharge and expedited referral instructions

Behavioral

The intervention for subjects with LVH on research POCUS will consist of three elements: 1) disclosure of presence of LVH to subject, ED team and primary care physician (PCP) (if applicable); 2) educational discharge instructions describing high BP, HTN, LVH, implications for development of cardiovascular disease (such as development of heart failure, stroke), options for treatment (lifestyle, medications) and importance of follow-up; A preliminary version will be refined prior to the start of the trial by feedback from ED physicians and patients. Refinement will target content, phrasing, and literacy level. 3) referral to outpatient care, consisting of one of two options, based on whether the subject has an established PCP. For subjects with existing PCP, the study team will call the office, inform about study participation, LVH findings, and secure a follow-up appointment. For those with no PCP, study team will arrange for follow-up to special clinic.

Primary outcomes

  1. Prevalence of LVH by POCUS

    Time frame: Day 1

    LVH point prevalence will be determined based on ultrasound measurements of left ventricular wall thickness and/or left ventricular mass, expressed as percentage of total population enrolled in the study.

Secondary outcomes

  1. Prevalence of LVH stratified by race, ethnicity and gender

    Time frame: through the end of the study, approximately 6 months

    Prevalence of LVH stratified by race, ethnicity and gender, if sample size allows this. LVH point prevalence by subgroups will be expressed as percentage of patients meeting LVH criteria of total enrolled population in that subgroup (eg men, women, African American, etc).

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

    Time frame: 3 months post-intervention

    Rate of successful follow-up in group of subjects with LVH on POCUS at 3 months post intervention, expressed as percentage of total subjects with successful follow-ups. Successful follow-up is defined as: a clinic appointment was made (either virtual or in-person) and subject presented to this appointment.

  3. Rate of treatment in group of subjects with LVH on POCUS

    Time frame: 3 months post-intervention

    Rate of treatment in group of subjects with LVH on POCUS at 3 months post intervention. Treatment is defined as new medication prescribed for blood pressure management following the ED visit where enrollment occurred.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Robert E. Leet and Clara Guthrie Patterson Trust

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.