Comparison of spironolactone and amiloride on home blood pressure in resistant hypertensio
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 118
1) Age 19-75
2) Patients with resistant hypertension
A. 1st screening: Even while taking three or more types of antihypertensive medications including diuretics without changing the dose for 3 months, the average office systolic blood pressure measured in three times is 140-180 mmHg and daytime systolic blood pressure is =135 mmHg.
B. 2nd screening: An average systolic blood pressure of home blood pressure monitoring is =135 mmHg during the run-in period of antihypertensive drugs including diuretics (Sevikar HCT 5/20 / 12.5 mg).
3) Patients with resistant hypertension who have agreed to participate in the study: when they have the ability to write a written consent in accordance with the Korean Good Clinical Practice (KGCP) and local laws.
4) Patients who can change the currently used antihypertensive treatment to Sevikar HCT 5/20/ 12.5mg without giving unacceptable risk (investigator's judgment)
1) White-coat uncontrolled hypertension
2) Severe hypertension (WHO classification criteria grade 3 average diastolic blood pressure = 110 mmHg or average systolic blood pressure = 180 mmHg)
3) Known cardiovascular disease (including stroke and TIA), including a history of angina, heart failure, myocardial infarction or revascularization, or cerebrovascular disease prior to 6 months
4) Congestive heart failure of III-IV according to NYHA functional classification
5) Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia that the investigator has deemed clinically meaningful.
6) Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or stenosis on the mitral valve
7) Renal insufficiency (basal estimated glomerular filtration rate (eGFR) <50 ml / min / 1.73m2)
8) Hyperkalemia (> 5.0 mmol / L, which can be reconfirmed if errors are suspected in the results)
9) Gastrointestinal diseases that can cause potential malabsorption
10) the gastro-intestinal tract is severely narrowed; Kock pouch (a continent pouch formed by the terminal ileum after colectomy)
11) Bile stasis or biliary obstruction
12) liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels > 2-fold the normal upper limit (ULN)
13) Pregnant or fertile women who are not contraceptive or woman who are lactating
14) Intolerant to thest drug/drug group or its components
15) Subjects who are currently participating in other clinical trials and who have taken other investigational product within the past month.
16) Subjects who have condition or a disease that may impede the completion of the test, according to the investigator's opinion
17) If assigned to treatment for this trial in the past
18) Uncorrected sodium or fluid depletion
19) History of drug or alcohol dependence within 6 months
20) The combination of medications known to affect blood pressure, except those permitted by the protocol.
21) Other clinical conditions that, as determined by the investigator, cannot be safely completed according to the protocol or that the investigational product cannot be safely used
22) a history of secondary hypertension that cannot be corrected
23) Taking spironolactone or amiloride within 3 months from the time of screening
24) If discontinued due to side effects of spironolactone or amiloride
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the change of average home systolic blood pressure at week 12 from the introduction phase between spironolactone group and amiloride group
- Secondary Outcome Measures
Name Time Method Comparison of target blood pressure achivement rates between spironolactone group and amiloride group;Comparison of home average night systolic blood pressures between spironolactone group and amiloride group