Clinical trial NCT04470284: Mobile App for BP Control
Official title: Self-Monitoring of and Feed-back Using APP. in TReatment of UnconTroled Blood Pressure (SMART-BP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 186
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients with essential hypertension aged 19 years and above.
2. Patients with essential hypertension who are taking one or more antihypertensive drugs.
3. 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.
4. Patients voluntarily consent to participate in this clinical trial
5. Patients who can use a smartphone

Exclusion Criteria:

1. 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.
2. Patients with a mean systolic BP ≥ 200 mmHg or diastolic BP ≥ 110 mmHg at the screening visit.
3. 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.
4. Patients with uncontrolled diabetes (HbA1c ≥ 9.0%).
5. 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.
6. Patients with symptomatic orthostatic hypotension.
7. Patients with a history of malignant tumors, including leukemia and lymphoma, within the past 5 years.
8. Patients with a history of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus.
9. 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.
10. 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.
11. Patients with shock.
12. Patients with a history of alcohol or drug abuse.
13. Patients with potential pregnancy or breastfeeding.
14. Patients who will be judged as both legally and psychologically inadequate to participate in the clinical study by the investigator.
15. Patients who have participated in clinical studies with other investigational drug products within 4 weeks prior to screening.

Primary outcomes:
measure: mean home systolic BP change
timeFrame: 24 weeks
measure: Drug adherence
timeFrame: 24 weeks
Secondary outcomes:
measure: Diastolic BP change
timeFrame: 12 weeks and 24 week
measure: office BP change
timeFrame: 12 weeks and 24 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Guro Hospital
state: Guro
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Seoul National Univeristy Bundang Hospital
name: Dong-Ju Choi, MD, PhD
role: STUDY_CHAIR
References:
citation: Choi 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.