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

NCT05730309 | Recruiting

• 2 other identifiers: 2000034381000
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Ventricular Hypertrophy

Outcome Measures

Primary Outcomes (1)

• Prevalence of LVH by POCUS

  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.

  Day 1

Secondary Outcomes (3)

• Prevalence of LVH stratified by race, ethnicity and gender

  through the end of the study, approximately 6 months

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

  3 months post-intervention

• Rate of treatment in group of subjects with LVH on POCUS

  3 months post-intervention

Study Arms (1)

Feasibility: Disclosure, customized discharge and expedited referral instructions

EXPERIMENTAL

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)

Behavioral: Customized discharge and expedited referral instructions

Interventions

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.

Feasibility: Disclosure, customized discharge and expedited referral instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Robert E. Leet and Clara Guthrie Patterson Trust: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Cristiana Baloescu, MD, MPH

CONTACT

(203) 737-2644; cristiana.baloescu@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Emergency Medicine

Model Details: From the prospective cohort enrolled in Aim 1, after performing the POCUS study, we will offer subjects with LVH on POCUS the three-element intervention (disclosure regarding presence of LVH, pre-specified discharge instruction and referral). Subjects without LVH on POCUS will receive usual ED care and pre-specified discharge instructions about high blood pressure.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: October 15, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)