Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Amlodipine; Hydrochlorothiazide; Sacubitril and valsartan sodium hydrate drug combination; Spironolactone; Valsartan

Criteria

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