NCT05713916Completed
Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy
A Pragmatic Clinical Trial Assessing the Effect of a Targeted Notification and Clinical Support Pathway on the Diagnostic Evaluation and Treatment of Individuals With Left Ventricular Hypertrophy
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
The electronic health record contains vast amounts of cardiovascular data, including potential clues that an individual may have unrecognized cardiac conditions. One important example is the finding of thickened heart muscle -- known as left ventricular hypertrophy (LVH) -- on echocardiograms (heart ultrasounds). If the underlying cause of LVH is untreated, individuals are at an increased risk of developing more severe pathology. As the most common cause of LVH, hypertension and its downstream consequences account for more cardiovascular deaths than any other modifiable risk factor. Critically, many individuals have signs of cardiac damage from hypertension before it is diagnosed or treated. Despite this evidence, there are often gaps in healthcare delivery that contribute to substandard recognition and treatment. Thus, there is an urgent need to validate alternative cost-effective screening and intervention strategies. Echocardiograms are ordered by many specialties and for numerous indications. Even when LVH is reported, the finding may be underappreciated and not prompt further evaluation. Whether data from prior echocardiograms can be harnessed to improve patient care through a centralized intervention is unknown. Accordingly, the goal of this randomized pragmatic clinical trial is to study the impact of a centralized clinical support pathway on the diagnosis and treatment of hypertension and the recognition of LVH-associated diseases in individuals with evidence of thickened heart muscle on previously performed echocardiograms.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 648 (actual)
- First submitted
- 26 Jan 2023
- Start date
- 20 Mar 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05713916
What you commit to
- Study type: Interventional
- Participants enrolled: 648
- From 20 Mar 2023 to the primary completion date, 28 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous outpatient blood pressure medication prescription
Other illness
- History of prosthetic heart valve
- History of heart or lung transplantation
- Active cancer treatment plan
- Dementia
Other
- Moderate or severe aortic stenosis
- Severe concentric LVH
- Asymmetric LVH
- Bicuspid aortic valve
- Known cardiomyopathy (or had an outpatient visit diagnosis for a cardiomyopathy)
- Autonomic dysfunction
- Active pregnancy
- Individuals whose primary address is in a nursing home or long-term care facility
Who the study is looking for
- Age 30-75 years
- Transthoracic echocardiogram as of 1/1/2019
- LVH on echocardiogram
- Mass General Brigham PCP affiliation with at least 1 PCP practice visit within the last 24 months
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.