Hypertrophy, Left VentricularNOTIFY-LVHNCT05713916
Effect of a Targeted Notification and Clinical Support Pathway on Individuals With Left Ventricular Hypertrophy
A study testing Intervention: Population Health Coordinator in people with Hypertrophy, Left Ventricular and Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertrophy, Left Ventricular, Hypertension, Cardiomyopathies
- What is being tested?
- Intervention: Population Health Coordinator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current or previous outpatient blood pressure medication prescription
- Moderate or severe aortic stenosis
- Severe concentric LVH
- Asymmetric LVH
- History of prosthetic heart valve
- Bicuspid aortic valve
Show all 13Show fewer
- Known cardiomyopathy (or had an outpatient visit diagnosis for a cardiomyopathy)
- Autonomic dysfunction
- History of heart or lung transplantation
- Active cancer treatment plan
- Active pregnancy
- Dementia
- Individuals whose primary address is in a nursing home or long-term care facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
The main questions our trial aims to answer are:
- Can a centralized intervention designed to support and alert clinicians to the presence of LVH in their patients who are not being treated with blood pressure medications increase the diagnosis and treatment of hypertension?
- Can a centralized clinical support intervention aimed at thoroughly screening for hypertension in individuals with LVH lead to an increase in the diagnosis of other causes of thickened heart muscle such as infiltrative and genetic cardiomyopathies?
For subjects randomized to the intervention arm, centralized population health coordinators will notify the established longitudinal specialty provider (cardiologist or nephrologist) or the primary care physician (PCP) that their patient has a recent echocardiogram demonstrating LVH. The outpatient clinician will be notified via the electronic health record 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. Through a structured correspondence with the identified clinician, the population health coordinator will offer to schedule a dedicated visit for the provider and their patient to discuss the finding of LVH. Additionally, the population health coordinator will offer to coordinate 24-hour ambulatory blood pressure monitoring before or after the patient visit as part of the evaluation of LVH. Finally, for subjects without established cardiovascular care and whose etiology of LVH remains undetermined, the population health coordinator will offer to coordinate a visit with a cardiologist to discuss the finding of LVH.
Researchers will compare subjects randomized to the intervention arm against those randomized to the observation arm to determine if there are: (1) higher rates of initiation of blood pressure medications, (2) increased diagnoses of hypertension, and (3) increased diagnoses of alternate causes of thickened heart muscle in subjects randomized to the intervention arm of the trial.
- Being tested
- Intervention: Population Health Coordinator
- Keywords
- Left ventricular hypertrophy, Pragmatic clinical trial
- Medical subject headings
- Hypertrophy, Left Ventricular, Hypertension, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Population Health CoordinatorOther
After being notified of the finding of LVH in their patient, the population health coordinator will offer to schedule a dedicated visit for the provider and their patient to discuss this finding through a structured correspondence. Additionally, the population health coordinator will offer to coordinate 24-hour ambulatory blood pressure monitoring before or after the patient visit as part of the evaluation of LVH. Finally, for patients without established cardiovascular care and whose etiology of LVH remains undetermined, the population health coordinator will offer to coordinate a visit with a cardiologist to discuss the finding of LVH.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Population Health Coordinator | Experimental | 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. Receives: Other: Intervention: Population Health Coordinator |
| Observation: Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are initiated on an antihypertensive medication
Collected from electronic health record data based on electronic prescribing data
Measured: 12 months from the start of follow-up
Secondary outcomes (2)
Number of participants who receive new diagnoses of hypertension
Collected from electronic health record data
Measured: 12 months from the start of follow-up
Number of participants who are diagnosed with alternate causes of LVH (e.g., infiltrative cardiomyopathy, hypertrophic cardiomyopathy, etc.) that were not previously identified
Collected from electronic health record data
Measured: 12 months from the start of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start20 Mar 2023
- Primary completion28 Jun 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypertrophy, Left VentricularStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized pragmatic clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason H. Wasfy, M.D.,M.Phil., Massachusetts General Hospital
- Investigators
- Jason H Wasfy, MD, Principal investigator, Massachussets General HospitalAdam N Berman, MD, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713916
- Sponsor's protocol ID
- 2022P002383
- Acronym
- NOTIFY-LVH
- Status last verified
- Nov 2024
- First submitted
- 26 Jan 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study completion, we will make every effort to make de-identified subject-level data available to other researchers upon reasonable request. Individual patient data that will be available upon reasonable request will include data that are presented in our study's main publication.
Publications
Cheng S, Claggett B, Correia AW, Shah AM, Gupta DK, Skali H, Ni H, Rosamond WD, Heiss G, Folsom AR, Coresh J, Solomon SD. Temporal trends in the population attributable risk for cardiovascular disease: the Atherosclerosis Risk in Communities Study. Circulation. 2014 Sep 2;130(10):820-8. doi: 10.1161/CIRCULATIONAHA.113.008506. Epub 2014 Aug 11.
PubMed 25210095Sakhuja S, Colvin CL, Akinyelure OP, Jaeger BC, Foti K, Oparil S, Hardy ST, Muntner P. Reasons for Uncontrolled Blood Pressure Among US Adults: Data From the US National Health and Nutrition Examination Survey. Hypertension. 2021 Nov;78(5):1567-1576. doi: 10.1161/HYPERTENSIONAHA.121.17590. Epub 2021 Oct 13.
PubMed 34644171Washington AE, Coye MJ, Boulware LE. Academic Health Systems' Third Curve: Population Health Improvement. JAMA. 2016 Feb 2;315(5):459-60. doi: 10.1001/jama.2015.18550. No abstract available.
PubMed 26836726Scirica BM, Cannon CP, Fisher NDL, Gaziano TA, Zelle D, Chaney K, Miller A, Nichols H, Matta L, Gordon WJ, Murphy S, Wagholikar KB, Plutzky J, MacRae CA. Digital Care Transformation: Interim Report From the First 5000 Patients Enrolled in a Remote Algorithm-Based Cardiovascular Risk Management Program to Improve Lipid and Hypertension Control. Circulation. 2021 Feb 2;143(5):507-509. doi: 10.1161/CIRCULATIONAHA.120.051913. Epub 2020 Nov 17. No abstract available.
PubMed 33201729Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e484-e594. doi: 10.1161/CIR.0000000000000596. No abstract available.
PubMed 30354654Berman AN, Ginder C, Sporn ZA, Tanguturi V, Hidrue MK, Shirkey LB, Zhao Y, Blankstein R, Turchin A, Wasfy JH. Natural Language Processing for the Ascertainment and Phenotyping of Left Ventricular Hypertrophy and Hypertrophic Cardiomyopathy on Echocardiogram Reports. Am J Cardiol. 2023 Nov 1;206:247-253. doi: 10.1016/j.amjcard.2023.08.109. Epub 2023 Sep 13.
PubMed 37714095Berman AN, Ginder C, Wang XS, Borden L, Hidrue MK, Searl Como JM, Daly D, Sun YP, Curry WT, Del Carmen M, Morrow DA, Scirica B, Choudhry NK, Januzzi JL, Wasfy JH. 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 (NOTIFY-LVH). Am Heart J. 2023 Nov;265:40-49. doi: 10.1016/j.ahj.2023.06.014. Epub 2023 Jul 14.
PubMed 37454754Berman AN, Hidrue MK, Ginder C, Shirkey L, Kwatra J, O'Kelly AC, Murphy SP, Searl Como JM, Daly D, Sun YP, Curry WT, Del Carmen MG, Blankstein R, Dodson JA, Morrow DA, Scirica BM, Choudhry NK, Januzzi JL Jr, Wasfy JH. Leveraging Preexisting Cardiovascular Data to Improve the Detection and Treatment of Hypertension: The NOTIFY-LVH Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):686-695. doi: 10.1001/jamacardio.2025.0871.
PubMed 40162953
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05713916
- Acronym / sponsor ID
- NOTIFY-LVH / 2022P002383
- Keywords
- Left ventricular hypertrophy, Pragmatic clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main questions our trial aims to answer are:
- Can a centralized intervention designed to support and alert clinicians to the presence of LVH in their patients who are not being treated with blood pressure medications increase the diagnosis and treatment of hypertension?
- Can a centralized clinical support intervention aimed at thoroughly screening for hypertension in individuals with LVH lead to an increase in the diagnosis of other causes of thickened heart muscle such as infiltrative and genetic cardiomyopathies?
For subjects randomized to the intervention arm, centralized population health coordinators will notify the established longitudinal specialty provider (cardiologist or nephrologist) or the primary care physician (PCP) that their patient has a recent echocardiogram demonstrating LVH. The outpatient clinician will be notified via the electronic health record 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. Through a structured correspondence with the identified clinician, the population health coordinator will offer to schedule a dedicated visit for the provider and their patient to discuss the finding of LVH. Additionally, the population health coordinator will offer to coordinate 24-hour ambulatory blood pressure monitoring before or after the patient visit as part of the evaluation of LVH. Finally, for subjects without established cardiovascular care and whose etiology of LVH remains undetermined, the population health coordinator will offer to coordinate a visit with a cardiologist to discuss the finding of LVH.
Researchers will compare subjects randomized to the intervention arm against those randomized to the observation arm to determine if there are: (1) higher rates of initiation of blood pressure medications, (2) increased diagnoses of hypertension, and (3) increased diagnoses of alternate causes of thickened heart muscle in subjects randomized to the intervention arm of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized pragmatic clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: Population Health Coordinator | Experimental | Other: Intervention: Population Health CoordinatorFor 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. |
| Observation: Usual Care | No 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Current or previous outpatient blood pressure medication prescription
- Moderate or severe aortic stenosis
- Severe concentric LVH
- Asymmetric LVH
- History of prosthetic heart valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention: Population Health CoordinatorAfter being notified of the finding of LVH in their patient, the population health coordinator will offer to schedule a dedicated visit for the provider and their patient to discuss this finding through a structured correspondence. Additionally, the population health coordinator will offer to coordinate 24-hour ambulatory blood pressure monitoring before or after the patient visit as part of the evaluation of LVH. Finally, for patients without established cardiovascular care and whose etiology of LVH remains undetermined, the population health coordinator will offer to coordinate a visit with a cardiologist to discuss the finding of LVH. | Other | Intervention: Population Health Coordinator |
Primary outcome
Number of participants who are initiated on an antihypertensive medication
Time frame: 12 months from the start of follow-up
Collected from electronic health record data based on electronic prescribing data
2 secondary outcomes
Number of participants who receive new diagnoses of hypertension
Time frame: 12 months from the start of follow-up
Number of participants who are diagnosed with alternate causes of LVH (e.g., infiltrative cardiomyopathy, hypertrophic cardiomyopathy, etc.) that were not previously identified
Time frame: 12 months from the start of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 25210095Cheng S, Claggett B, Correia AW, Shah AM, Gupta DK, Skali H, Ni H, Rosamond WD, Heiss G, Folsom AR, Coresh J, Solomon SD. Temporal trends in the population attributable risk for cardiovascular disease: the Atherosclerosis Risk in Communities Study. Circulation. 2014 Sep 2;130(10):820-8. doi: 10.1161/CIRCULATIONAHA.113.008506. Epub 2014 Aug 11.
- Background: PubMed 34644171Sakhuja S, Colvin CL, Akinyelure OP, Jaeger BC, Foti K, Oparil S, Hardy ST, Muntner P. Reasons for Uncontrolled Blood Pressure Among US Adults: Data From the US National Health and Nutrition Examination Survey. Hypertension. 2021 Nov;78(5):1567-1576. doi: 10.1161/HYPERTENSIONAHA.121.17590. Epub 2021 Oct 13.
- Background: PubMed 26836726Washington AE, Coye MJ, Boulware LE. Academic Health Systems' Third Curve: Population Health Improvement. JAMA. 2016 Feb 2;315(5):459-60. doi: 10.1001/jama.2015.18550. No abstract available.
- Background: PubMed 33201729Scirica BM, Cannon CP, Fisher NDL, Gaziano TA, Zelle D, Chaney K, Miller A, Nichols H, Matta L, Gordon WJ, Murphy S, Wagholikar KB, Plutzky J, MacRae CA. Digital Care Transformation: Interim Report From the First 5000 Patients Enrolled in a Remote Algorithm-Based Cardiovascular Risk Management Program to Improve Lipid and Hypertension Control. Circulation. 2021 Feb 2;143(5):507-509. doi: 10.1161/CIRCULATIONAHA.120.051913. Epub 2020 Nov 17. No abstract available.
- Background: PubMed 30354654Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018 Oct 23;138(17):e484-e594. doi: 10.1161/CIR.0000000000000596. No abstract available.
- Background: PubMed 37714095Berman AN, Ginder C, Sporn ZA, Tanguturi V, Hidrue MK, Shirkey LB, Zhao Y, Blankstein R, Turchin A, Wasfy JH. Natural Language Processing for the Ascertainment and Phenotyping of Left Ventricular Hypertrophy and Hypertrophic Cardiomyopathy on Echocardiogram Reports. Am J Cardiol. 2023 Nov 1;206:247-253. doi: 10.1016/j.amjcard.2023.08.109. Epub 2023 Sep 13.
- Background: PubMed 37454754Berman AN, Ginder C, Wang XS, Borden L, Hidrue MK, Searl Como JM, Daly D, Sun YP, Curry WT, Del Carmen M, Morrow DA, Scirica B, Choudhry NK, Januzzi JL, Wasfy JH. 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 (NOTIFY-LVH). Am Heart J. 2023 Nov;265:40-49. doi: 10.1016/j.ahj.2023.06.014. Epub 2023 Jul 14.
- Derived from this study: PubMed 40162953Berman AN, Hidrue MK, Ginder C, Shirkey L, Kwatra J, O'Kelly AC, Murphy SP, Searl Como JM, Daly D, Sun YP, Curry WT, Del Carmen MG, Blankstein R, Dodson JA, Morrow DA, Scirica BM, Choudhry NK, Januzzi JL Jr, Wasfy JH. Leveraging Preexisting Cardiovascular Data to Improve the Detection and Treatment of Hypertension: The NOTIFY-LVH Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):686-695. doi: 10.1001/jamacardio.2025.0871.
- Individual participant dataSharing planned: Yes. After study completion, we will make every effort to make de-identified subject-level data available to other researchers upon reasonable request. Individual patient data that will be available upon reasonable request will include data that are presented in our study's main publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason H Wasfy, MD principal investigator
Massachussets General Hospital
Adam N Berman, MD study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Population Health Coordinator in people with Hypertrophy, Left Ventricular and Hypertension, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who are initiated on an antihypertensive medication (time frame: 12 months from the start of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713916, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.