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

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

Kitahara Hideki

Chiba University Hospital

1-8-1 Inohana Chuo-ku, Chiba

hkitahara@chiba-u.jp

Kitahara Hideki

Chiba University Hospital

1-8-1 Inohana Chuo-ku, Chiba

+81-43-222-7171

hkitahara@chiba-u.jp

Recruiting

Sept. 22, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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).

1) Acute heart failure (NYHA class IV)
2) Systolic blood pressure <110 mmHg
3) Severe hepatic dysfunction (Child-Pugh class C)
4) Severe renal dysfunction (serum creatinine > 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

Both

Aortic stenosis

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)]
If a patient was on ACE-I or ARB before TAVI, it will be continued. If not, Candesartan 4mg/day will be started 1-2 days before TAVI.
The day after TAVI, ACE-I or ARB will be switched to Entresto 100mg/day (50mg twice daily).
A patient has tolerability to Entresto, dosage will be stepwisely increased to 400mg/day (200mg twice daily) 2-4 weeks apart. Entresto will be continued at least until 6 months follow-up.
[Control group]
A patient receives conventional medications.

NT-proBNP value at 6 months follow-up.

[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

+81-43-226-2616

Aug. 23, 2022

No

none