Clinical efficacy evaluation of Guanxinning tablet in the prevention and treatment of hypertension and Coronary heart disease complicated with heart failure
- Conditions
- hypertension and Coronary heart disease complicated with heart failure
- Registration Number
- ITMCTR2100005201
- Lead Sponsor
- Shenzhen Luohu People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria for chronic heart failure of coronary heart disease, and belong to stage B, NYHA grade I or stage C, NYHA grade II-III;
(2) The thickness of the interventricular septum (IVS) obtained by echocardiography> 11mm;
(3) Diagnosed as mild to moderate essential hypertension (grade 1 or 2 essential hypertension);
Diastolic blood pressure and systolic blood pressure in the consulting room without the influence of drugs need to meet the following conditions: ?Measured by sitting blood pressure (average of 3 measurements): 90mmHg=average diastolic blood pressure<110 mmHg and/or ?Measured by sitting blood pressure (taken from 3 measurements) Average): 140mmHg=average systolic blood pressure<180mmHg;
(4) Both men and women are between 18 and 80 years old;
(5) Accept the drug treatment voluntarily and sign an informed consent form.
(1) Severe essential hypertension (sitting systolic blood pressure =180 mmHg and/or sitting diastolic blood pressure =110mmHg) and poor drug control, malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.; Known secondary hypertension;
(2) The condition was unstable within 4 weeks before enrollment (such as hospitalization due to aggravated heart failure and confirmed by records); myocardial infarction or coronary revascularization occurred within 2 months before enrollment; Stroke; paroxysmal atrial fibrillation occurred within 4 weeks before enrollment and the drug dose for atrial fibrillation treatment was not stable, or permanent atrial fibrillation or atrial flutter;
(3) Patients with other heart diseases: pulmonary heart disease, congenital heart disease, moderate to severe pulmonary hypertension, moderate to severe stenosis or regurgitation of the heart valve, or severe aortic regurgitation, cardiomyopathy, and heart failure caused by arrhythmia; heartbeat Tachy attacks or cardiogenic shock, unstable angina pectoris, uncontrollable malignant arrhythmia; those undergoing cardiothoracic surgery, the subject has a planned left ventricular remodeling operation, a history of heart transplantation or a planned heart transplantation Technique
(4) Active tuberculosis;
(5) Autoimmune diseases, such as systemic lupus erythematosus and giant cell myocarditis;
(6) There is a history of any malignant tumor;
(7) Obesity, body mass index (BMI)> 30kg/m2;
(8) Patients with abnormal liver and kidney function indexes (ALT, AST, Scr exceed the upper limit of the normal reference range by 2 times; GFR=60ml/(min·1.73m2));
(9) Use other traditional Chinese medicines for promoting blood circulation and removing blood stasis, or use anticoagulant drugs, such as warfarin. The specific combination of drugs should be based on the actual clinical needs of the investigator;
(10) People with allergies, or allergies to multiple drugs and foods, or patients who are known to be allergic to the research drug (including its ingredients);
(11) Those who have pregnancy plans or are pregnant or lactating women, or those who cannot guarantee effective contraception during the trial period;
(12) Mental illness with poor control of the condition and drug users who have not given up drugs;
(13) Patients who participated in other clinical trials within the past 3 months;
(14) The investigator believes that there are patients with unsuitable factors for selection.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Echocardiogram;
- Secondary Outcome Measures
Name Time Method 6-minute walk test;NT-proBNP;NYHA Heart Function Classification;Angina pectoris symptom score;Lee's heart failure score;Changes of DBP and SBP in sitting position;