HypertensionAI-HTNNCT07218198
Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension
A study testing Standard medical treatment and Clinical Decision Support Tool in people with Hypertension and Hypertension (HTN), run by The Cleveland Clinic at 1 site in United States.
Trial summary
The goal of this clinical trial is to study whether having a clinical decision support (CDS) tool available to clinician use will more effectively lower BP 4 weeks after an outpatient visit compared with usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hypertension (HTN), Blood Pressure, High
- What is being tested?
- Standard medical treatment and Clinical Decision Support Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years of age or older
- Electronic Health Record (EHR) of hypertension AND prescribed at least one BP lowering medication
- Office systolic BP of 130 mmHg or higher
- Willing and able to comply with the study instructions AND attend a scheduled study visit
Who cannot join
- Women who are pregnant, plan to become pregnant, or are breast-feeding
- Know heart failure with reduced ejection fraction and a left ventricular ejection fraction of less than 40%
- End-stage kidney disease currently undergoing renal replacement therapy, or an eGFR < 15ml/min/1.73m2
- In the opinion of the investigator, any other condition that will preclude participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic
Cleveland, Ohio, 44195
Jeffrey Maxwell, 216-978-8873, MAXWELJ2@ccf.org
Vivian Jeffers, 216-636-9628, jefferv@ccf.org
About this study
Official title: A Stepped Wedged, Cluster Randomized Clinical Trial to Evaluate the Efficacy of a Clinical Decision Support Tool in the Treatment of Uncontrolled Hypertension
The goal of this clinical trial is to study whether having a clinical decision support (CDS) tool available to clinician use will more effectively lower BP 4 weeks after an outpatient visit compared with usual care. The main objective is to assess the impact of the CDS tool, that is embedded with the electronic medical record (EMR), that is available during outpatient clinical encounters, on blood pressure (BP) changes among participants with uncontrolled hypertension.
Participants will:
Visit the clinic 4 weeks, after their initial clinician visit, for a BP check.
- Being tested
- Standard medical treatment, Clinical Decision Support Tool
- Keywords
- Uncontrolled Hypertension, Hypertension, Blood Pressure, High Blood Pressure, Artificial Intelligence, AI
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical treatmentOther
Also called hypertension, hypertension management
Clinicians will use their own standard of care recommendations for combinations of medications.
Clinical Decision Support ToolOther
Also called hypertension, hypertension management
Clinical Decision Support Tool embedded into the Electronic Medical Record to help support clinicians to prescribe more effective combinations of medications
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care for Hypertension Management | Active comparator | Clinicians will use their own standard of care recommendations for combinations of medications. Receives: Other: Standard medical treatment |
| Clinical Decision Support Tool | Experimental | Clinical Decision Support Tool embedded into the Electronic Medical Record to help support clinicians to prescribe more effective combinations of medications Receives: Other: Clinical Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic automated office blood pressure (AOBP)
Clinical Decision Support (CDS) Tool is available, Change from baseline in systolic automated office blood pressure (AOBP) at 4 weeks.
Measured: 4 weeks
Secondary outcomes (1)
Change in diastolic automated office blood pressure (AOBP)
Percentage of Participants with controlled BP (<130mmHg), Change from baseline in diastolic automated office blood pressure (AOBP) at 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- The study is a stepped wedge cluster randomized trial. All participating clinicians will receive access to the CDS tool, but clinicians will have different start dates for the tool.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke Laffin, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218198
- Sponsor's protocol ID
- IRB# 25-1135
- Acronym
- AI-HTN
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Whelton 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: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
PubMed 29133354Mroz T, Griffin M, Cartabuke R, Laffin L, Russo-Alvarez G, Thomas G, Smedira N, Meese T, Shost M, Habboub G. Predicting hypertension control using machine learning. PLoS One. 2024 Mar 20;19(3):e0299932. doi: 10.1371/journal.pone.0299932. eCollection 2024.
PubMed 38507433Darricarrere C, Jacquot E, Bricout S, Louis C, Benard M, Poulter NR. Uncontrolled blood pressure and therapeutic inertia in treated hypertensive patients: A retrospective cohort study using a UK general practice database. J Clin Hypertens (Greenwich). 2023 Oct;25(10):895-904. doi: 10.1111/jch.14699. Epub 2023 Sep 22.
PubMed 37740433
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped Wedged, Cluster Randomized Clinical Trial to Evaluate the Efficacy of a Clinical Decision Support Tool in the Treatment of Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT07218198
- Acronym / sponsor ID
- AI-HTN / IRB# 25-1135
- Keywords
- Uncontrolled Hypertension, Hypertension, Blood Pressure, High Blood Pressure, Artificial Intelligence, AI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Oct 2025 (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 goal of this clinical trial is to study whether having a clinical decision support (CDS) tool available to clinician use will more effectively lower BP 4 weeks after an outpatient visit compared with usual care. The main objective is to assess the impact of the CDS tool, that is embedded with the electronic medical record (EMR), that is available during outpatient clinical encounters, on blood pressure (BP) changes among participants with uncontrolled hypertension.
Participants will:
Visit the clinic 4 weeks, after their initial clinician visit, for a BP check.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a stepped wedge cluster randomized trial. All participating clinicians will receive access to the CDS tool, but clinicians will have different start dates for the tool.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care for Hypertension Management | Active comparator | Other: Standard medical treatmentClinicians will use their own standard of care recommendations for combinations of medications. |
| Clinical Decision Support Tool | Experimental | Other: Clinical Decision Support ToolClinical Decision Support Tool embedded into the Electronic Medical Record to help support clinicians to prescribe more effective combinations of medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 18 years of age or older
- Electronic Health Record (EHR) of hypertension AND prescribed at least one BP lowering medication
- Office systolic BP of 130 mmHg or higher
- Willing and able to comply with the study instructions AND attend a scheduled study visit
Key exclusion criteria (4 listed)
- Women who are pregnant, plan to become pregnant, or are breast-feeding
- Know heart failure with reduced ejection fraction and a left ventricular ejection fraction of less than 40%
- End-stage kidney disease currently undergoing renal replacement therapy, or an eGFR < 15ml/min/1.73m2
- In the opinion of the investigator, any other condition that will preclude participation in the study
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 |
|---|---|---|
| Standard medical treatmentAlso: hypertension, hypertension managementClinicians will use their own standard of care recommendations for combinations of medications. | Other | Standard of Care for Hypertension Management |
| Clinical Decision Support ToolAlso: hypertension, hypertension managementClinical Decision Support Tool embedded into the Electronic Medical Record to help support clinicians to prescribe more effective combinations of medications | Other | Clinical Decision Support Tool |
Primary outcome
Change in systolic automated office blood pressure (AOBP)
Time frame: 4 weeks
Clinical Decision Support (CDS) Tool is available, Change from baseline in systolic automated office blood pressure (AOBP) at 4 weeks.
1 secondary outcome
Change in diastolic automated office blood pressure (AOBP)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 29133354Whelton 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: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
- Results publication: PubMed 38507433Mroz T, Griffin M, Cartabuke R, Laffin L, Russo-Alvarez G, Thomas G, Smedira N, Meese T, Shost M, Habboub G. Predicting hypertension control using machine learning. PLoS One. 2024 Mar 20;19(3):e0299932. doi: 10.1371/journal.pone.0299932. eCollection 2024.
- Results publication: PubMed 37740433Darricarrere C, Jacquot E, Bricout S, Louis C, Benard M, Poulter NR. Uncontrolled blood pressure and therapeutic inertia in treated hypertensive patients: A retrospective cohort study using a UK general practice database. J Clin Hypertens (Greenwich). 2023 Oct;25(10):895-904. doi: 10.1111/jch.14699. Epub 2023 Sep 22.
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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.
Luke Laffin, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical treatment and Clinical Decision Support Tool in people with Hypertension and Hypertension (HTN), run by The Cleveland Clinic 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 4 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Wisniewski, RN (216-312-4282, wisniel@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic automated office blood pressure (AOBP) (time frame: 4 weeks). 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 NCT07218198, which also lists 3 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 7 Oct 2026.