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Clinical Support Pathway for Heart Enlargement (NOTIFY-LVH Trial)

N/A

Waitlist Available

Led By Jason H Wasfy, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Age 30-75 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months from the start of follow-up

Awards & highlights

NOTIFY-LVH Trial Summary

This trial will study the impact of a centralized clinical support pathway on the diagnosis & treatment of hypertension & recognition of thickened heart muscle on echos, which is associated w/ increased risk of severe pathology.

Who is the study for?

This trial is for individuals aged 30-75 with thickened heart muscle on an echocardiogram since Jan 1, 2019. They must have visited a Mass General Brigham primary care physician in the last two years. It's not for those on blood pressure meds, with severe heart valve issues, certain types of LVH, past major heart or lung surgeries, active cancer treatment or pregnancy, dementia, or living in long-term care facilities.Check my eligibility

What is being tested?

The study tests if using data from previous heart ultrasounds to guide patient care can better diagnose and treat high blood pressure and recognize diseases associated with thickened heart muscle. A Population Health Coordinator will be part of the centralized clinical support pathway being evaluated.See study design

What are the potential side effects?

Since this intervention involves a healthcare coordination approach rather than medication or surgery, traditional side effects are not applicable. However, there may be indirect effects related to changes in healthcare management.

NOTIFY-LVH Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 30 and 75 years old.

NOTIFY-LVH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months from the start of follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months from the start of follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months from the start of follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who are initiated on an antihypertensive medication

Secondary outcome measures

Number of participants who are diagnosed with alternate causes of LVH (e.g., infiltrative cardiomyopathy, hypertrophic cardiomyopathy, etc.) that were not previously identified

Number of participants who receive new diagnoses of hypertension

NOTIFY-LVH Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention: Population Health CoordinatorExperimental Treatment1 Intervention

For subject randomized to the intervention arm, population health coordinators will notify the established longitudinal specialty clinician (cardiologist or nephrologist) or the primary care provider (PCP) that their patient has a recent echocardiogram demonstrating left ventricular hypertrophy (LVH). The outpatient clinician will be notified via the electronic health record (EHR) messaging system that the finding of LVH -- in the absence of significant valvular heart disease or a previously diagnosed cardiomyopathy -- may reflect undiagnosed or untreated hypertension.

Group II: Observation: Usual CareActive Control1 Intervention

Those subjects randomized to the observation arm will receive usual care and their clinicians will not be notified about the finding of LVH on a prior echocardiogram until after study completion.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,197,755 Total Patients Enrolled

1 Trials studying Cardiomyopathy

25 Patients Enrolled for Cardiomyopathy

Adam N Berman, MDStudy DirectorBrigham and Women's Hospital

Jason H Wasfy, MDPrincipal InvestigatorMassachussets General Hospital

Media Library

Population Health Coordinator Clinical Trial Eligibility Overview. Trial Name: NCT05713916 — N/A

Cardiomyopathy Research Study Groups: Observation: Usual Care, Intervention: Population Health Coordinator

Cardiomyopathy Clinical Trial 2023: Population Health Coordinator Highlights & Side Effects. Trial Name: NCT05713916 — N/A

Population Health Coordinator 2023 Treatment Timeline for Medical Study. Trial Name: NCT05713916 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this research protocol open to those below the age of 60?

"The eligibility requirements for this clinical trial dictates that patients must be between 30 and 75 years old."

Answered by AI

Is it possible for me to partake in this research endeavor?

"Eligible applicants must be between 30 and 75 years old and have been diagnosed with cardiomyopathy. The trial is enrolling a maximum of 600 people for the duration of the study."

Answered by AI

Have there been any recent changes to enrollment criteria for this experiment?

"According to clinicaltrials.gov, the current recruitment phase for this particular medical study is inactive, having been initially posted on March 20th of 2023 and last updated a day later. Despite that, there are still 974 other trials looking for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy

Jason H. Wasfy, M.D.,M.Phil. 2023. "Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05713916.

All > Hypertrophy