Hypertension
Conditions
Interventions
Single dose group:Standard antihypertensive drug treatment+Qishen Yiqi Drop Pill 0.52g/time+placebo 0.52g/time, 3 times a day
Double dose group:Standard antihypertensive drug treatment+Qishen Yiqi Dropping Pill 1.04g/time, 3 times a day
placebo group:Standard antihypertensive drug treatment+placebo 1.04g/time, 3 times a day
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects included in the study must meet all five of the following criteria: (1) Sign a written informed consent form; (2) Male or female, aged 18-80 years; (3) Clinical diagnosis of primary hypertension and current blood pressure reaching the target, i.e. SBP/DBP<140/90mmHg. For patients whose blood pressure has not yet reached the standard, it is possible to adjust the antihypertensive drug regimen to reduce their blood pressure to<140/90mmHg during the screening period of the study: Hypertension is defined as: Without using antihypertensive drugs, blood pressure in the consulting room was measured three times on different days, with systolic blood pressure (SBP) = 140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg;or a patient has a history of hypertension and is currently using antihypertensive drugs, although his blood pressure is lower than 140/90mmHg. (4) Echocardiography indicates left ventricular hypertrophy: left ventricular mass index (LVMI), male = 115g/m2, female = 95g/m2. (5) Patients who currently do not have renin angiotensin system inhibition (ACEI/ARB) in their blood pressure medication agree to increase or adjust ACEI/ARB regardless of whether their current blood pressure is up to standard.
Exclusion criteria
Exclusion criteria: (1) Those who have contraindications to the use of Qishen Yiqi Dropping Pills or have allergic reactions to this product; (2) There are contraindications to ACEI/ARB drug use; (3) Secondary hypertension; (4) After adjusting the drug regimen during the screening period, the blood pressure still does not reach the target, i.e. SBP/DBP = 140/90mmHg; (5) Those who refuse to adjust the antihypertensive drug regimen during the study; (6) Patients with heart failure with LVEF = 50% indicated by previous and current UCG; (7) Patients with coronary heart disease who have a previous history of myocardial infarction, PCI or CABG history, or patients with suspected coronary heart disease who have symptoms of angina pectoris; (8) Other organic heart diseases, including valvular heart disease, congenital heart disease, cardiomyopathy, myocarditis, etc; (9) Ischemic or hemorrhagic stroke within 6 months; (10) Severe arrhythmia or poorly controlled tachycardia that affects the image quality of echocardiography; (11) HscTnI/CK-MB increased (higher than the upper limit of the normal value detected by the hospital during the screening period); (12) Uncontrollable diabetes, HbA1c = 8.5%; (13) Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 3 times or more of the upper limit of the normal range; (14) Acute or chronic renal insufficiency: serum creatinine (Scr)>115umol/L or eGFR<60mL/min.172m2; (15) Abnormal blood routine, including: white blood cell count<4 × 10^9/L, platelet count<100 × 10^9/L,HGB<90g/L (16) Any situation that the researcher believes can significantly limit the completion of patient follow-up (such as long-term travel, language disorders, mental disorders) (17) Existence of serious coexisting diseases leading to life expectancy = 6 months; (18) Pregnant and lactating women, women of childbearing age who have not taken medication or device contraception, or women who have positive urine pregnancy tests (HCG testing); (19) Have a history of alcohol and/or drug abuse in the past 5 years; (20) People who have participated in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes and differences of E/e ' measured by echocardiography at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes and differences in cardiac diastolic function indicators measured by echocardiography after 6 months, including E/A, E peak deceleration time (DT), E ', left atrial volume index, pulmonary systolic pressure, and tricuspid regurgitation velocity;Changes and differences in echocardiographic measurements after 6 months, including ventricular wall thickness, left ventricular mass index (LVMI), LVEF, long axis strain, and left atrial strain;Changes and differences in LVEF, ventricular septal thickness, and left ventricular free wall thickness measured by left ventricular contrast echocardiography after 6 months;Changes and differences in LVEF, ventricular septal thickness, left ventricular free wall thickness, and left atrial area measured by cardiac contrast enhanced magnetic resonance imaging after 6 months;Changes in 6-minute walking test and EQ-5D scores after 6 months; | — |
Countries
China
Contacts
Public ContactYong Huo
Peking University First Hospital
Outcome results
None listed