Patients with essential hypertension who have poor blood pressure control despite combination therapy with ARBs and CCBs
Conditions
Interventions
Sacubitril/Valsartan Group
Indapamido Group
Sponsors
Yokohama Sakae Kyosai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have been receiving combination therapy with an ARB and a CCB at or above the usual dose for at least 4 weeks prior to screening, without any changes in dosage 2) Patients who, at the start of the study, do not meet either of the following criteria: a target office blood pressure of <130/80 mmHg, or an average early-morning home blood pressure of <125/75 mmHg over the past week 3) Patients who, after receiving a thorough explanation regarding participation in this trial, provided written informed consent of their own free will based on full understanding 4) 18 years of age or older
Exclusion criteria
Exclusion criteria: 1. Under 18 years of age 2. Patients who have received treatment with thiazide diuretics or Sacubitril/Valsartan within the past year 3. Patients with severe hypertension(persistent systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg). 4. Patients with clearly secondary hypertension due to underlying conditions such as primary aldosteronism, renovascular hypertension, or pheochromocytoma 5. Patients requiring renal replacement therapy or with severe renal impairment (eGFR<30 mL/min/1.73 m2) 6. Severe proteinuria at the nephrotic level (protein-to-creatinine ratio>3.5 g/gCr) 7. Severe hepatic impairment (e.g., cirrhosis, Child-Pugh Class C), 8.NYHA Class III or higher, poorly controlled severe chronic heart failure 9. End-stage malignant disease 10. Patients with severe infections 11. Pregnancy 12. Patients deemed unsuitable for enrollment by the attending physician due to poor adherence to medical visits or medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving the target blood pressure in the clinic at the final evaluation (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Achievement rate of morning home blood pressure at the final assessment (Week 12) 2)Change from baseline to the final assessment (Week 12) in the following clinical data 3)Office blood pressure, morning blood pressure, clinical findings (weight, pulse, eGFR, uric acid, serum potassium, HbA1c, albuminuria or proteinuria (all per gram of creatinine), estimated salt intake based on sodium, potassium, and creatinine concentrations in spot urine (using the Tanaka formula), and sodium-to-potassium ratio, AST, ALT, gamma-GTP, LDL cholesterol, HDL cholesterol, triglycerides 4)Nighttime blood pressure at the final evaluation (for the implementation example only) 5)Safety evaluation (adverse events (mild or severe), discontinuation of treatment (reason and date), event occurrence information (fatal myocardial infarction, coronary artery disease requiring PCI, cardiovascular death, hospitalization for heart failure, stroke (cerebral infarction, cerebral hemorrhage), all-cause mortality, initiation of renal replacement therapy, progression to eGFR <15 mL/min/1.73m2, progression to overt proteinuria) 6)Analysis by presence or absence of beta-blockers or chronic heart failure 7)Analysis by presence or absence of chronic kidney disease 8)Analysis by estimated daily salt intake 9)Analysis by age (65 years) 10)Analysis by presence or absence of diabetes 11)Analysis by Sacubitril/Valsartan dosage 12)Continuation of treatment beyond 12 weeks (final assessment includes treatment regimen and blood pressure values at 1 year, rate of blood pressure target achievement, and renal function) | — |
Countries
Japan
Contacts
Public ContactKyoji Chiba
Yokohama Sakae Kyosai Hospital Department of Nephrology
Outcome results
None listed