Status:
COMPLETED
Low-dose Quadruple Combination Therapy in Patients With Hypertension
Lead Sponsor:
The Third Xiangya Hospital of Central South University
Conditions:
Hypertension
Arterial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 combin...
Detailed Description
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 partic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05377203
Start Date
July 13 2022
End Date
July 4 2023
Last Update
July 18 2023
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013