HypertensionSMART-BPNCT04470284
Mobile App for BP Control
A study testing Mobile Application and Standard SMBP in people with Hypertension, run by Seoul National University Bundang Hospital at 5 sites in South Korea.
Trial summary
SMART-BP is a randomized, controlled study in which hypertensive patients are allocated to self monitoring of blood pressure monitoring (SMBP) only group or SMBP with mobile App based feed-back algorithm (SMBP-App) group. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Mobile Application and Standard SMBP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 1 Sep 2019to 15 Mar 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with essential hypertension aged 19 years and above.
- Patients with essential hypertension who are taking one or more antihypertensive drugs.
- Patients whose average systolic and diastolic BP measured 3 times on the reference arm in the sitting position during Visit 1 is greater than 140 mmHg and 90 mmHg, respectively.
- Patients voluntarily consent to participate in this clinical trial
- Patients who can use a smartphone
Who cannot join
- Patients with a history of secondary hypertension or suspected secondary hypertension, including coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease.
- Patients with a mean systolic BP ≥ 200 mmHg or diastolic BP ≥ 110 mmHg at the screening visit.
- Patients with ≥ 20 mmHg difference between the highest and the lowest sitting systolic BP or ≥ 10 mmHg difference between highest and lowest diastolic BP, which is confirmed by triplicate measurements from the reference arm at screening.
- Patients with uncontrolled diabetes (HbA1c ≥ 9.0%).
- Patients who have been continuously taking other medications such as systemic steroids, thyroid hormones, oral contraceptives (except for menopausal hormone replacement therapy), psychiatric drugs, non-steroidal anti-inflammatory drugs, sympathetic drugs, and immune suppressants, which have the potential to affect BP.
- Patients with symptomatic orthostatic hypotension.
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- Patients with a history of malignant tumors, including leukemia and lymphoma, within the past 5 years.
- Patients with a history of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus.
- Patients with clinically significant kidney and liver diseases, such as those on dialysis, liver cirrhosis, biliary obstruction, and hepatic failure, or those who show the following findings during the screening visit:
- Alanine transaminase or aspartate transaminase level is at least 3 times higher than the normal upper limit;
- Total bilirubin level is more than twice the normal upper limit;
- Blood urea nitrogen level is more than twice the normal upper limit;
- Alkaline phosphatase level is more than twice the normal upper limit;
- Creatinine clearance level is less than 10 mL/min.
- Patients with a history of the following diseases in the past 6 months, which are determined to be clinically significant by the investigator:
- Heart failure (NYHA class III and IV), ischemic heart diseases (coronary artery diseases, such as angina pectoris and myocardial infarction), peripheral vascular diseases, hemodynamically significant valve stenosis, and arrhythmia.
- Severe cerebrovascular events, including stroke, cerebral infarction, and cerebral hemorrhage.
- Patients with shock.
- Patients with a history of alcohol or drug abuse.
- Patients with potential pregnancy or breastfeeding.
- Patients who will be judged as both legally and psychologically inadequate to participate in the clinical study by the investigator.
- Patients who have participated in clinical studies with other investigational drug products within 4 weeks prior to screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Hallym University Sacred Heart Hospital
Anyang
Seoul National University Bundang Hospital
Seongnam, 13620
Korea Univ. Guro Hospital
Seoul, Guro, 08308
Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul
Kyung Hee University Hospital
Seoul
About this study
Official title: Self-Monitoring of and Feed-back Using APP. in TReatment of UnconTroled Blood Pressure (SMART-BP)
SMART-BP is a randomized, controlled study in which hypertensive patients are allocated to self monitoring of blood pressure monitoring (SMBP) only group or SMBP with mobile App based feed-back algorithm (SMBP-App) group. The App based feed-back algorithm will provide the patients with instruction in response to the measured BP value, e.g. remind of taking drug, if high blood pressure is detected.
The primary outcomes are mean systolic BP change and drug compliance at 24-weeks. Secondary endpoints include mean diastolic BP change at 12-week, mean systolic and diastolic BP change at 12 and 24 weeks, and drug compliance.
Read the detailed description
This trial is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP with mobile health application (SMBP-App) compared with SMBP alone.
Patients with hypertension will be randomly assigned to SMBP-App (intervention) and SMBP along (control) groups. In SMBP group the patients perform home blood pressure measurement and usual care. In SMBP-App group the patients perform home blood pressure and receive extra alarm and instructions from the mobile application in response to the obtained blood pressure value.
The aim of this study is to evaluate whether SMBP-App is superior to SMBP alone in terms of blood pressure reduction and improved drug compliance in patients with hypertension.
- Conditions
- Hypertension
- Being tested
- Mobile Application, Standard SMBP
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationOther
SMBP with mobile App based feed-back algorithm. The App based feed-back algorithm will remind the patients of taking drug to improve BP control and drug compliance.
Standard SMBPOther
Standard treatment (SMBP-alone)
| Study group | Role | What they receive |
|---|---|---|
| SMBP_only | Active comparator | Standard treatment with SMBP Receives: Other: Standard SMBP |
| SMBP_mobile_app | Experimental | SMBP with mobile App based feed-back algorithm Receives: Other: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean home systolic BP change
mean home systolic BP change from baseline to 24 weeks (Visit 2)
Measured: 24 weeks
Drug adherence
Drug adherence using pill count
Measured: 24 weeks
Secondary outcomes (2)
Diastolic BP change
mean home diastolic BP change from baseline
Measured: 12 weeks and 24 week
office BP change
office systolic or diastolic BP change from baseline
Measured: 12 weeks and 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Sep 2019
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
- Investigators
- Dong-Ju Choi, MD, PhD, Study chair, Seoul National Univeristy Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470284
- Sponsor's protocol ID
- SMART-BP
- Acronym
- SMART-BP
- Status last verified
- May 2023
- First submitted
- 6 Jul 2020
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon M, Hur T, Park SJ, Jo SH, Kim EJ, Kim SJ, Hussain M, Hua CH, Lee S, Choi DJ. Self-Monitoring of Blood Pressure and Feedback via Mobile App in Treatment of Uncontrolled Hypertension: The SMART-BP Randomized Clinical Trial. Mayo Clin Proc. 2025 May;100(5):840-853. doi: 10.1016/j.mayocp.2024.09.018. Epub 2025 Mar 5.
PubMed 40047759Choi DJ, Park JJ, Yoon M, Park SJ, Jo SH, Kim EJ, Kim SJ, Lee S. Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial. Korean Circ J. 2022 Oct;52(10):785-794. doi: 10.4070/kcj.2022.0133.
PubMed 36217600
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring of and Feed-back Using APP. in TReatment of UnconTroled Blood Pressure (SMART-BP)
- ClinicalTrials.gov ID
- NCT04470284
- Acronym / sponsor ID
- SMART-BP / SMART-BP
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 14 Jul 2020 (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.
SMART-BP is a randomized, controlled study in which hypertensive patients are allocated to self monitoring of blood pressure monitoring (SMBP) only group or SMBP with mobile App based feed-back algorithm (SMBP-App) group. The App based feed-back algorithm will provide the patients with instruction in response to the measured BP value, e.g. remind of taking drug, if high blood pressure is detected.
The primary outcomes are mean systolic BP change and drug compliance at 24-weeks. Secondary endpoints include mean diastolic BP change at 12-week, mean systolic and diastolic BP change at 12 and 24 weeks, and drug compliance.
Detailed description
This trial is a prospective, randomized, open-label, multicenter trial to evaluate the efficacy of SMBP with mobile health application (SMBP-App) compared with SMBP alone.
Patients with hypertension will be randomly assigned to SMBP-App (intervention) and SMBP along (control) groups. In SMBP group the patients perform home blood pressure measurement and usual care. In SMBP-App group the patients perform home blood pressure and receive extra alarm and instructions from the mobile application in response to the obtained blood pressure value.
The aim of this study is to evaluate whether SMBP-App is superior to SMBP alone in terms of blood pressure reduction and improved drug compliance in patients with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMBP_only | Active comparator | Other: Standard SMBPStandard treatment with SMBP |
| SMBP_mobile_app | Experimental | Other: Mobile ApplicationSMBP with mobile App based feed-back algorithm |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients with essential hypertension aged 19 years and above.
- Patients with essential hypertension who are taking one or more antihypertensive drugs.
- Patients whose average systolic and diastolic BP measured 3 times on the reference arm in the sitting position during Visit 1 is greater than 140 mmHg and 90 mmHg, respectively.
- Patients voluntarily consent to participate in this clinical trial
- Patients who can use a smartphone
Key exclusion criteria (22 listed)
- Patients with a history of secondary hypertension or suspected secondary hypertension, including coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease.
- Patients with a mean systolic BP ≥ 200 mmHg or diastolic BP ≥ 110 mmHg at the screening visit.
- Patients with ≥ 20 mmHg difference between the highest and the lowest sitting systolic BP or ≥ 10 mmHg difference between highest and lowest diastolic BP, which is confirmed by triplicate measurements from the reference arm at screening.
- Patients with uncontrolled diabetes (HbA1c ≥ 9.0%).
- Patients who have been continuously taking other medications such as systemic steroids, thyroid hormones, oral contraceptives (except for menopausal hormone replacement therapy), psychiatric drugs, non-steroidal anti-inflammatory drugs, sympathetic drugs, and immune suppressants, which have the potential to affect BP.
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 |
|---|---|---|
| Mobile ApplicationSMBP with mobile App based feed-back algorithm. The App based feed-back algorithm will remind the patients of taking drug to improve BP control and drug compliance. | Other | SMBP_mobile_app |
| Standard SMBPStandard treatment (SMBP-alone) | Other | SMBP_only |
Primary outcome
mean home systolic BP change
Time frame: 24 weeks
mean home systolic BP change from baseline to 24 weeks (Visit 2)
Drug adherence
Time frame: 24 weeks
Drug adherence using pill count
2 secondary outcomes
Diastolic BP change
Time frame: 12 weeks and 24 week
office BP change
Time frame: 12 weeks and 24 week
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 6 May 2023.
- Derived from this study: PubMed 40047759Yoon M, Hur T, Park SJ, Jo SH, Kim EJ, Kim SJ, Hussain M, Hua CH, Lee S, Choi DJ. Self-Monitoring of Blood Pressure and Feedback via Mobile App in Treatment of Uncontrolled Hypertension: The SMART-BP Randomized Clinical Trial. Mayo Clin Proc. 2025 May;100(5):840-853. doi: 10.1016/j.mayocp.2024.09.018. Epub 2025 Mar 5.
- Derived from this study: PubMed 36217600Choi DJ, Park JJ, Yoon M, Park SJ, Jo SH, Kim EJ, Kim SJ, Lee S. Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial. Korean Circ J. 2022 Oct;52(10):785-794. doi: 10.4070/kcj.2022.0133.
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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.
Dong-Ju Choi, MD, PhD study chair
Seoul National Univeristy Bundang Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application and Standard SMBP in people with Hypertension, run by Seoul National University Bundang Hospital at 5 sites in South Korea.
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 5 inclusion and 22 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
mean home systolic BP change (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT04470284, which also lists 2 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 6 May 2023.