Effect and Safety of Chronotherapy Compared to Conventional therapy in the Elderly Patients with Nocturnal Hypertensio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007518
- Lead Sponsor
- Chungbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Patients aged 65 or older with hypertension and enrolled in the targeted blood pressure study (HOWOLD-BP trial, 2018-09-015) in the treatment of hypertension among elderly hypertension subjects. 1) Patients whose blood pressure is controlled by taking stable doses in the last 3 months. 3) Among patients with confirmed night hypertension in blood pressure monitoring during activities, those who voluntarily agreed are targeted.
It is the same as the exclusion criteria of the study on prognosis analysis according to target blood pressure when treating hypertension in elderly hypertension subjects (HOWOLD-BP trial, 2018-09-015). Patients who meet any of the following criteria cannot participate in this clinical trial.
1) Subjects with all suspected history of secondary hypertension, such as aortic stenosis, hyperaldosterone, renal stenosis, cushing disease, chromium-friendly cytoma, and polycystic nephrotic disease, and all suspected of secondary hypertension.
2) Resistant hypertension subjects whose blood pressure is controlled to less than 140/90 mmHg using three or more antithrombotic drugs, including diuretics, or four or more antithrombotic drugs including diuretics, with blood pressure controlled to less than 140/90 mmHg.
3) Subjects with orthostatic hypotension (One minute standing SBP < 110 mmHg) accompanied by symptoms at the time of screening
4) Subject to uncontrolled diabetes whose HbA1C value is defined to be 10% or higher at the time of screening.
5) Subject to chronic kidney disease with maintenance dialysis or estimated GFR 1515 mL/min/1.73 m2
6) Subjects who have undergone acute coronary syndrome, heart surgery, and urgent percutaneous coronary intervention (PCI) within the last 3 months.
7) Subject to systolic heart failure with a left ventricular uvula rate of less than 40% in the past history.
8) Subjects with hypertrophic obstructive cardiomyopathy, aortic stenosis, severe valve disease, and hemodynamically significant congenital heart disease.
9) Subject to acute stroke diagnosed with stroke within the last 3 months.
10) Subjects with known moderate or malignant retinopathy such as retinal bleeding, vision impairment, and retinal microarachnoid within the last 6 months.
11) Subjects who have clinically significant liver disease or whose AST/ALT level is 3 times or more than the normal upper limit.
12) Uncontrolled thyroid function.
13) Those who participated in other clinical trials within 4 weeks of screening or those who plan to participate in other clinical trials during this intervention study.
14) If there are other serious reasons for restricting participation and progress in research at the discretion of the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method dizziness accompanied by symptoms, syncope, fall down
- Secondary Outcome Measures
Name Time Method Emerging cardiovascular disease and worsening