Resistant Hypertension Clinical Trial
Official title:
Effects and Safety of Sacubitril/Valsartan Versus Valsartan on Refractory Hypertension: The EOSORH Trial
Resistant hypertension (RH) accounted for a considerable proportion of patients with hypertension. It has been revealed to impose certain adverse effects on the prognosis of patients with cardiovascular diseases. The antihypertensive effect of sacubitril/valsartan being fully confirmed in previous studies, there were no related randomized controlled trials (RCT) about this potency among Chinese patients with RH. The investigators designed this study to evaluated effects and safety of sacubitril/valsartan versus valsartan on Chinese patients with RH.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | March 31, 2023 |
Est. primary completion date | October 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Clinical diagnosis of resistant hypertension - =18 and =75 years old at the time of randomization - Must agree to comply with all requirements and sign the informed consent form Exclusion Criteria: - unwilling to sign informed consent. - Severe renal insufficiency - Research related drug contraindications - secondary hypertension - Cardiovascular event - Persistent arrhythmia, valvular heart disease, and class III-IV heart failure or left ventricular ejection fraction <45%. - Severe liver function impairment (Child-Pugh C), biliary cirrhosis and/or cholestasis - History of angioedema and asthma - Woman of childbearing age who do not take effective contraceptive measures or pregnant or breastfeeding - Allergic to drugs related to the study - Suffering from serious tumor-related diseases, receives tumor-related treatment, or has a life expectancy of less than 2 years - Planning to join other clinical trials - Anticipated changes in medical conditions - Need to take study-related drugs for reasons other than hypertension - Suffering from other diseases that may prevent the patient from participating fully period of the study - Other any concomitant conditions - Must continuously take any drugs that affect the results |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141. — View Citation
Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, Chalmers J, Rodgers A, Rahimi K. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016 Mar 5;387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8. Epub 2015 Dec 24. Review. — View Citation
Kario K, Shin J, Chen CH, Buranakitjaroen P, Chia YC, Divinagracia R, Nailes J, Hoshide S, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Tay JC, Teo BW, Turana Y, Zhang Y, Park S, Van Minh H, Wang JG. Expert panel consensus recommendations for ambulatory blood pressure monitoring in Asia: The HOPE Asia Network. J Clin Hypertens (Greenwich). 2019 Sep;21(9):1250-1283. doi: 10.1111/jch.13652. — View Citation
Kario K, Sun N, Chiang FT, Supasyndh O, Baek SH, Inubushi-Molessa A, Zhang Y, Gotou H, Lefkowitz M, Zhang J. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study. Hypertension. 2014 Apr;63(4):698-705. doi: 10.1161/HYPERTENSIONAHA.113.02002. Epub 2014 Jan 20. — View Citation
Lamirault G, Artifoni M, Daniel M, Barber-Chamoux N, Nantes University Hospital Working Group On Hypertension. Resistant Hypertension: Novel Insights. Curr Hypertens Rev. 2020;16(1):61-72. doi: 10.2174/1573402115666191011111402. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the change in 24 hours average ambulatory systolic pressure from baseline to 8 weeks after randomization | the change in 24 hours average ambulatory systolic blood pressure (in mmHg) from baseline to 8 weeks after randomization | 8 weeks after randomization | |
Secondary | Change in 24 hours average ambulatory diastolic blood pressure, daytime and night-time blood pressure and office blood pressure | Change in 24 hours average ambulatory diastolic blood pressure, daytime systolic blood pressure, night-time systolic blood pressure, daytime diastolic blood pressure, night-time diastolic blood pressure, office systolic blood pressure and office diastolic blood pressure | 8 weeks after randomization | |
Secondary | Change in level of cardiac marker reflecting the heart failure | serum N-terminal pro-brain natriuretic peptide (NT-proBNP in pg/ml) | 8 weeks after randomization | |
Secondary | Change in level of cardiac marker reflecting myocardial damage | cardiac troponin T (cTnT in pg/ml) | 8 weeks after randomization | |
Secondary | Change in level of novel cardiac marker reflecting the heart failure | suppression of Tumorigenicity 2 (sST2 in ng/ml) | 8 weeks after randomization | |
Secondary | Change in level of cardiac marker reflectting myocardial metabolism | cyclic guanosine monophosphate (cGMP in pmol/l) | 8 weeks after randomization | |
Secondary | Change in level of estimated glomerular filtration rate | Change in level of estimated glomerular filtration rate (eGFR in mL/min/1.73m^2). | 8 weeks after randomization | |
Secondary | Change in level of urinary albumin to creatinine ratio | Change in level of urinary albumin to creatinine ratio (in mg/mmol). | 8 weeks after randomization | |
Secondary | the control rate of blood pressure | The control rate of blood pressure. Blood pressure control was defined as a blood pressure of less than 140/90 mmHg after medical treatment. | 8 weeks after randomization | |
Secondary | Change in left atrium diameter determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in left atrium diameter (LA in mm) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in left ventricular mass index determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in left ventricular mass index (LVMI in g/m^2) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in left ventricular end diastolic volume index determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in left ventricular end diastolic volume index (LVEDVI in ml/m^2) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in left ventricular end systolic volume index determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in left ventricular end systolic volume index (LVESVI in ml/m^2) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in left ventricular ejection fraction determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in left ventricular ejection fraction (LVEF in %) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in E/A determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in E/A determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.The E/A ratio is an echocardiographic index that reflects the diastolic function of the heart Under normal circumstances, E/A > 1. | 8 weeks after randomization | |
Secondary | Change in E/e' determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in E/e' determined by ultrasonic cardiogram and three-dimensional .The E/E' ratio is of great clinical significance in determining the diastolic function of the heart. If the E/E' ratio is <8, diastolic dysfunction can generally be ruled out. If the E/E' ratio is > 15, it generally indicates the existence of diastolic dysfunction. | 8 weeks after randomization | |
Secondary | Change in left ventricular overall longitudinal peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in left ventricular overall longitudinal peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in overall radial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in overall radial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in overall circumstantial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in overall circumstantial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization | |
Secondary | Change in area strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging | Change in area strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging. | 8 weeks after randomization |
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