Status:
COMPLETED
Mobile App for BP Control
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
NA
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 algori...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT04470284
Start Date
September 1 2019
End Date
March 15 2021
Last Update
May 6 2023
Active Locations (5)
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1
Korea Univ. Guro Hospital
Seoul, Guro, South Korea, 08308
2
Hallym University Sacred Heart Hospital
Anyang, South Korea
3
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
4
Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea