About this trial
This study aims to compare the efficacy and safety of Sacubitril/Valsartan versus Valsartan in patients with essential hypertension and type 2 diabetic nephropathy over a 12-week treatment period, including two treatment groups, with a total of 297 eligible subjects randomly assigned in a 2:1 ratio to either the experimental group or the control group.Subjects will participate in the study through two phases: the screening period and the follow-up period.The primary outcome measure is the change in systolic blood pressure from baseline after 12 weeks of treatment.
Eligibility criteria
Qualifiers
Age 18 years or older, no gender restriction;
Diagnosed with mild to moderate primary hypertension (140 ≤ SBP < 180 mmHg and/or 90 ≤ DBP < 110 mmHg), including newly diagnosed or inadequately treated patients (those who have not followed previous medical advice and have uncontrolled blood pressure according to the investigator);
Diagnosed with type 2 diabetes (according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)), and meeting the following conditions: a) Continuously on ≥ 1 glucose control medication regimens (which may include long-acting insulin) for at least 12 weeks before screening, with a stable treatment regimen (i.e., the same medication and dosage) for at least 28 days before screening, and maintaining this regimen during the study. At the investigator's discretion, the dose of supplemental short-acting insulin can be adjusted as needed to achieve adequate glucose control; b) HbA1c level ≤ 10.5% and fasting (≥ 8 hours) plasma glucose level ≤ 13.3 mmol/L (if fasting glucose > 13.3 mmol/L, the investigator may repeat the test to determine eligibility);
Urine albumin/creatinine ratio (UACR) ≥ 30 mg/g in two measurements taken on separate days or eGFR < 60 mL/min/1.73 m²;
Disqualifiers
Presence of severe hypertension, malignant hypertension, hypertensive emergencies, or hypertensive crises;
History or evidence of secondary hypertension within 12 months before screening, including but not limited to any of the following: renovascular hypertension, renal parenchymal hypertension, unilateral or bilateral renal artery stenosis, coarctation of the aorta, primary aldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension;
History of angioedema (drug-related or other causes) within 12 months before screening;
Presence of diabetic ketoacidosis;
Trial design
Treatments tested in this trial
- Sacubitril/Valsartan
- Valsartan
Treatment groups
Sponsors and collaborators
Sichuan Academy of Medical Sciences
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Nanchong Central Hospital
Collaborator
The People's Hospital of Leshan
Collaborator
The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University
Collaborator
Chengdu First People's Hospital
Collaborator
Mianyang People's Hospital
Collaborator
Guan'an People's Hospital
Collaborator
Meishan Traditional Chinese Medicine Hospital
Collaborator
Qijiang District People's Hospital
Collaborator
Meishan People's Hospital
Collaborator
The First People's Hospital of Guangyuan
Collaborator
Dazhou Central Hospital
Collaborator