Initial Treatment With a Single Capsule Containing Quadruple Combination of Half Doses of Blood Pressure Medicines Versus Standard Dose Dual Therapy in Patients With Hypertension: A Single-center, Randomized, Double-blind, Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean systolic blood pressure of 24-hour
研究概览
简要总结
This study aims to compare the antihypertensive effect of initial treatment with a single capsule containing quadruple combination of half-dose of blood pressure medicines or standard dose dual combination in patients with hypertension.
详细描述
This is a single-center, randomized, double-blind, crossover trial, planning to enroll 90 patients with grade 1 and 2 hypertension in the Third Xiangya Hospital of Central South University. The participants will be divided into two groups randomly and treated with half-dose quadruple antihypertensive therapy (irbesartan 75mg+ metoprolol 23.75mg+ amlodipine 2.5mg+ indapamide 1.25mg) or with full-dose dual antihypertensive therapy (irbesartan 150mg+ amlodipine 5mg) for four weeks. After washing out with placebo for two weeks, the participants of the two groups will exchange their medication and be treated for another four weeks. The changes of blood pressure (including 24-hour ambulatory blood pressure, office blood pressure, and home blood pressure) and related adverse effects of the two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Persons except who make masking plan and conduct medicine coding, are all masked.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, < 80 years old；
- •Have never taken antihypertensive medications or have not taken antihypertensive medications in the past 1 month；
- •Patients with hypertension (meet the following two parameters to avoid white coat hypertension):a. Office Blood Pressure: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg measured 3 times on different days;b. ABPM: average blood pressure of 24h ≥130/80 mmHg; Or average blood pressure of daytime ≥135/85 mmHg; Or average blood pressure of night ≥120/70 mmHg;
- •Participate voluntarily and sign written informed consent.
排除标准
- •Confirmed or highly suspected secondary hypertension, such as primary aldosteronism, Cushing's syndrome, pheochromocytoma or paraganglioma, aortic constriction, renal arterial stenosis, renal hypertension, hyperthyroidism, etc.;
- •Severe hypertension: systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg in the consulting room or hypertensive emergency or urgency at the time of visit;
- •Differences in blood pressure of both upper limbs ≥20/10mmHg;
- •Allergic to irbesartan, metoprolol, amlodipine, indapamide and sulfonamides;
- •Cannot swallow tablets;
- •Pregnant and lactating women;
- •Possible reproductive needs during the trial;
- •Uncorrected electrolyte disorder (serum potassium > 5.5mmol/L or < 3.5mmol/L, serum sodium < 135mmol/L);
- •Severe organ dysfunction, including impaired renal function (GFR < 60mL /min/1.73m^2), impaired liver function (aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal), NYHF classification class IV for cardiac function;
- •Comorbidities lead to inaccurate blood pressure measurement, such as arrhythmia, etc.;
- •Comorbidities result in the prohibition or caution of the experimental drugs, such as: aortic stenosis, mitral valve stenosis, hypertrophic obstructive cardiomyopathy, bilateral renal artery stenosis or renal artery stenosis with solitary kidney, gout, hyperuricemia (serum uric acid >420μmol/L in men or 360μmol/L in women), acute coronary syndrome, sick sinus syndrome, degree II-III of atrioventricular block, severe peripheral vascular disease with high risk of gangrene, history or family history of angioedema;
- •Comorbidities affect the absorption, distribution, metabolism and excretion of the experimental drugs such as: gastrointestinal resection, gastrointestinal bypass surgery, sympathetic nerve resection or other operations, active inflammatory bowel disease, malignant tumors undergoing or planning to undergo radiotherapy or chemotherapy or targeted therapy, etc.;
- •Medications in use or about to be used may lead to the prohibition or caution of experimental drugs: such as ACEI, Aliskiren, lithium agent, etc.;
- •Medications in use or about to be used will interfere the results of this study, such as: hormones, Sacubitril valsartan and spironolactone for patients with chronic heart failure, Dapagliflozin and Liraglutide for patients with diabetes, and long-term medication for patients with chronic coronary heart disease, etc.;
- •Not appropriate for antihypertensive therapies of this trial evaluated by physician;
- •Participating in other clinical research that may affect the conduct of this study.
研究组 & 干预措施
Group A
Quadruple combination of half doses therapy for 4 weeks→Wash out for 2 weeks →Dual combination of standard dose therapy for 4 weeks.
干预措施: Quadruple combination of half doses therapy→Dual combination of standard dose therapy (Drug)
Group B
Dual combination of standard dose therapy for 4 weeks→Wash out for 2 weeks →Quadruple combination of half doses therapy for 4 weeks.
干预措施: Dual combination of standard dose therapy→ Quadruple combination of half doses therapy (Drug)
结局指标
主要结局
Mean systolic blood pressure of 24-hour
时间窗: Four weeks
The reduction of mean systolic blood pressure of 24-hour in Ambulatory Blood Pressure Monitoring (ABPM) after 4 weeks of medication (from baseline).
次要结局
- Office blood pressure(Four weeks)
- Heart rate(Four weeks)
- Mean systolic blood pressure of daytime and night(Four weeks)
- Mean diastolic blood pressure of 24-hour, daytime and night(Four weeks)
- Controlled rate of blood pressure(Four weeks)
- Morning blood pressure surge(Four weeks)
- Home blood pressure(Four weeks)