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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

Must not have

Bicuspid aortic valve

Active cancer treatment plan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months from the start of follow-up

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 30 and 75 years old.

Exclusion Criteria

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

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I have a bicuspid aortic valve.

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I am currently following a treatment plan for my cancer.

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I have been diagnosed with moderate or severe narrowing of my heart's aortic valve.

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I have had a heart or lung transplant.

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I am taking or have taken blood pressure medication.

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I have been diagnosed with cardiomyopathy.

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

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

Primary study objectives

Number of participants who are initiated on an antihypertensive medication

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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 / 7Eligibility criteria met