Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy
NCT Number: NCT06501651
Acronym: Hyper-Save
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Essential Hypertension|Type 2 Diabetes|Nephropathy
Interventions: DRUG: Sacubitril/Valsartan|DRUG: Valsartan
Sponsor: Sichuan Academy of Medical Sciences
Collaborators: The Second Affiliated Hospital of Chongqing Medical University|Nanchong Central Hospital|The People's Hospital of Leshan|The Affiliated Traditional Chinese Medicine Hospital Of Southwest Medical University|Chengdu First people's hospital|Mianyang People's Hospital|Guan'an People's Hospital|Meishan Traditional Chinese Medicine Hospital|Qijiang District People's Hospital|Meishan People's Hospital|The First People's Hospital of Guangyuan|Dazhou Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 297
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-04-10
Locations: Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China

Summary:
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.

Primary Outcome Measures: Reduction in 24-hour ambulatory systolic blood pressure(SBP), The comparison of the reduction in 24-hour ambulatory systolic blood pressure from baseline between the two groups, From enrollment to the end of treatment at 12 weeks
Secondary Outcome Measures: Reduction in 24-hour ambulatory diastolic blood pressure(DBP), The comparison of the reduction in 24-hour ambulatory diastolic blood pressure from baseline between the two groups, From enrollment to the end of treatment at 12 weeks|Changes in daytime and nighttime ambulatory blood pressure, The comparison of the changes in daytime and nighttime ambulatory blood pressure between the two groups. (The mean daytime blood pressure is defined as the average of hourly measurements taken between 6:00 and 22:00, and the mean nighttime is defined as the average of hourly measurements taken between 22:00 and 6:00.), From enrollment to the end of treatment at 12 weeks|Rate of dipper blood pressure restoration, The comparison of the proportion of subjects in each group who achieve a dipper blood pressure pattern, defined as a nighttime blood pressure reduction of 10-20% in both systolic and diastolic blood pressure., From enrollment to the end of treatment at 12 weeks|Rate of blood pressure achievement, The comparison of the proportion of subjects in each group who achieve blood pressure targets (SBP \< 130 mmHg and DBP \< 80 mmHg), From enrollment to the end of treatment at 12 weeks|Rate of hypertension treatment response, The comparison of the proportion of subjects in each group who achieve hypertension treatment response, defined as: SBP \< 140 mmHg and/or a reduction from baseline of ≥ 20 mmHg; DBP \< 90 mmHg and/or a reduction from baseline of ≥ 10 mmHg; both of them, From enrollment to the end of treatment at 12 weeks|Improvement in diabetes condition, Comparison of reductions in fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) between the two groups, From enrollment to the end of treatment at 12 weeks|Improvement in Renal Function, The comparison of reductions in serum creatinine, urine albumin/creatinine ratio, and blood urea nitrogen between the two groups, From enrollment to the end of treatment at 12 weeks|Medication utilization, The comparison of dose escalation proportions and the proportion of subjects requiring adjunctive nifedipine controlled-release tablets between the two groups, From enrollment to the end of treatment at 12 weeks|Safety assessments, Safety assessments included monitoring of all adverse events (AEs), serious AEs (SAEs), and regular monitoring of vital signs and clinical laboratory tests., From enrollment to the end of treatment at 12 weeks