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
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