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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

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 - Exploratory study to investigate the influence of ARNI in patients with hemodialysis and heart failure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050122
Enrollment
374
Registered
2023-02-01
Start date
2023-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Administer sacbitril valsartan. No administration of sacubitril-valsartan(Patients taking angiotensin converting enzyme inhibitor or angiotensin receptor blocker before this study should continue thes

Sponsors

Masuko Memorial Hospital
Lead Sponsor
Department of Cardiology, Nagoya City University Graduate School of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with hemodialysis 2)Patients with heart failure 3)Patients who can give a written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Composite endpoint (all cause death and hospitalizations for heart failure, ischemic heart disease, and stroke)

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYoshihiro Seo

Masuko Memorial Hospital Department of cardiology

yo-seo@med.nagoya-cu.ac.jp+81-52-451-1307

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026