A single-center, prospective, randomized, exploratory study to investigate the influence of ARNI (angiotensin receptor neprilysin inhibitor) in patients with hemodialysis and heart failure: SPREAD trial
Not Applicable
- Conditions
- Chronic heart failure
- Registration Number
- JPRN-UMIN000050122
- Lead Sponsor
- Masuko Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 374
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who had hypotension before or during the last 3-cycle hemodialysis 2)Hyperkalemia 3)Patients with severe liver disease 4)Patients with a history of hospitalization due to ischemic heart disease or stroke within 3 months. 5)Patients under an unstable heart failure condition 6)Patients with a life expectancy less than 1 year 7)Patients with acute phase disease requiring hospitalization 8)Patients with severe valvular disease 9)Patients with severe respiratory disease 10)Pregnant patients 11)Patients who are suspected of drug allergy to sacubitril-valsartan 12)Patients unable to communicate 13)Patients who are judged inappropriate for this study by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite endpoint (all cause death and hospitalizations for heart failure, ischemic heart disease, and stroke)
- Secondary Outcome Measures
Name Time Method 1) BNP, ANP, NT-proBNP value at 1 month and 1 year. 2) Echocardiographic parameters at 1 and 2 years. 3) Adverse events in sacubitril-valsartan group.