The efficacy of angiotensin receptor neprilysin inhibitor in patients after transcatheter aortic valve implantation.

Randomized, open-label, controlled study to evaluate the efficacy of angiotensin receptor neprilysin inhibitor in patients with aortic stenosis undergoing transcatheter aortic valve implantation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031220344

Enrollment

Registered

2022-09-22

Start date

2022-10-31

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

Aortic stenosis

Interventions

A patient who meets inclusion criteria, and has provided written informed consent to participate in this study, will be randomly assigned into 2 groups as shown below. [treatment group (Entresto group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A patient with aortic stenosis and the symptoms of heart failure requiring transcatheter aortic valve implantation based on "2020 Guideline on the Management of Valvular Heart Disease". 2) A patient who is scheduled transcatheter aortic valve implantation at Chiba university hospital. 3) A patient aged 70 years or older at the time of enrollment. 4) A patient who has provided written informed consent to participate in this study (if the patient can not sign by oneself, it is acceptable that a family or a person following a family writes on behalf).

Exclusion criteria

Exclusion criteria: 1) Acute heart failure (NYHA class IV) 2) Systolic blood pressure 3.0mg/dL) 5) Hemodialysis 6) Hyperkalemia (serum K >5.5 mEq/L) 7) Bilateral renal artery stenosis 8) A history of angioedema 9) A patient with diabetes on Aliskiren fumarate 10) A patient without written informed consent 11) A patient whom the investigator considers to be ineligible as a subject

Design outcomes

Primary

Measure	Time frame
NT-proBNP value at 6 months follow-up.	—

Secondary

Measure	Time frame
[Efficacy] Change in NT-proBNP value at 6 months follow-up Systolic pulmonary artery pressure at 6 months follow-up Edema scale at 6 months follow-up NYHA class at 6 months follow-up Increas or decrease in diuretics Change in body weight Cardiovascular events (death, admission for heart failure, myocardial infarction, etc.) [Safety] Incidence of adverse events Prevalence of patients with serum K >5.5 mEq/L Prevalence of patients with symptomatic hypotension	—

Measure

Time frame

[Efficacy] Change in NT-proBNP value at 6 months follow-up Systolic pulmonary artery pressure at 6 months follow-up Edema scale at 6 months follow-up NYHA class at 6 months follow-up Increas or decrease in diuretics Change in body weight Cardiovascular events (death, admission for heart failure, myocardial infarction, etc.) [Safety] Incidence of adverse events Prevalence of patients with serum K >5.5 mEq/L Prevalence of patients with symptomatic hypotension

—

Contacts

Public ContactHideki Kitahara

Chiba University Hospital

hkitahara@chiba-u.jp+81-43-222-7171

Outcome results

None listed

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