aortic dissection
Conditions
Interventions
Sacubitril-valsartan group:Sacubitril-valsartan
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1) Written informed consent must be obtained prior to any evaluation. 2) Male and female patients over the age of 18. 3) The diagnosis meets the criteria for aortic dissection. 4) Patients with mild to moderate hypertension, who have not received treatment or are currently receiving antihypertensive treatment. Specific requirements: ? For patients who have received treatment (with antihypertensive drugs within 4 weeks prior to Visit 101) at the time of randomization (Visit 201), msSBP must be = 120 mmHg and < 150 mmHg, and at the visit immediately before Visit 201 ( Must have msSBP =120mmHg and <150mmHg at visit 102 or 103). ? For patients who have not received treatment (newly diagnosed with essential hypertension or a history of hypertension but have not used any antihypertensive drugs for at least 4 weeks prior to Visit 101), it is mandatory at Visit 101 and Visit 201 msSBP=120mmHg and <150mmHg. 5) There must be an absolute difference of =15 mmHg in the patient's msSBP between Visit 201 and the visit immediately preceding this visit. 6) Able to communicate and comply with all study requirements and demonstrate good medication adherence (=80% adherence rate) during the run-in period (Phase 2).
Exclusion criteria
Exclusion criteria: Patients meeting the following criteria were excluded. 1) Women who are pregnant or breastfeeding (lactating), where pregnancy is defined as the female state in which pregnancy is confirmed by a positive human chorionic gonadotropin (hCG) laboratory test result and continues until the end of the pregnancy. 2) Females of childbearing potential, defined as all females who are biologically capable of becoming pregnant unless they are using a highly effective method of contraception during dosing for 5 times the terminal half-life of the study treatment. 3) Hypertension and the blood pressure level meets the mean sitting diastolic blood pressure msDBP=110mmHg and/or msSBP=160mmHg. 4) Patient reported a history of angioedema (drug-related or otherwise). 5) History or evidence of secondary hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary Hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension. 6) History of transient ischemic attack or any stroke during the 12 months prior to Visit 101. 7) History of myocardial infarction, coronary artery bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 101. 8) Angina pectoris currently requiring medical treatment (except for patients treated with oral or topical nitrates at stable doses). 9) Patients with poorly controlled type 1 or type 2 diabetes mellitus according to the investigator's clinical judgment. It is recommended that patients currently receiving diabetes treatment be treated with a stable dose of hypoglycemic medication for at least 4 weeks prior to Visit 101. 10) Previous or current diagnosis of heart failure (NYHA class II-IV). 11) Clinically significant valvular heart disease at Visit 101. 12) History or current diagnosis of the following cardiac abnormalities: ? Second or third degree AV block without a pacemaker. ? Clinically significant arrhythmias, including poorly controlled atrial fibrillation (ventricular rate = 120 bpm). ? Family history of long QT syndrome or torsades de pointes. 13) History of malignancy of any organ system (treated or untreated, with or without evidence of local recurrence or metastasis, except for localized basal cell carcinoma of the skin) within the past 5 years. 14) Known active liver disease or cirrhosis, or liver disease determined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) test results Evidence, or total bilirubin (TBL) > 2 × ULN or alkaline phosphatase (ALP) > 1.5 × ULN range at visit 101, or history of hepatic encephalopathy, history of esophageal varices, or history of portal venous shunt. 15) Patients receiving renal dialysis or a history of renal transplantation. 16) Any surgical or medical condition that can significantly alter the absorption, distribution, metabolism or excretion of any drug, including but not limited to any of the following: Gastrointestinal tract that the investigator considers clinically significant within 12 months prior to Visit 101 History of major surgery (eg, gastrectomy, gastrostomy, bowel resection, gastric bypass, gastric anastomosis, or gastric banding), current active inflammatory bowel disease or history of active inflammatory bowel disease . 17) The investigator believes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease in mean sitting systolic blood pressure relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean sitting systolic pressure;Mean sitting diastolic blood pressure;Pulse pressure in out-patient unit;24-hour mean dynamic systolic blood pressure;Successful blood pressure control;Mean sitting systolic pressure response;Mean sitting diastolic blood pressure response; | — |
Countries
China
Contacts
Public ContactXuyu He
Guangdong Provincial People's Hospital
Outcome results
None listed