KCT0004891招募中未知
SPironolactone versus Amiloride for treatment of REsistant hypertension (SPARE trial): A comparison of home blood pressure
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 75?(Year)（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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