NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1031220344

Registered date:22/09/2022

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAortic stenosis
Date of first enrollment22/09/2022
Target sample size84
Countries of recruitment
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeNT-proBNP value at 6 months follow-up.
Secondary Outcome[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

Key inclusion & exclusion criteria

Age minimum>= 70age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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).
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Hideki Kitahara
Address 1-8-1 Inohana Chuo-ku, Chiba Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail hkitahara@chiba-u.jp
Affiliation Chiba University Hospital
Scientific contact
Name Hideki Kitahara
Address 1-8-1 Inohana Chuo-ku, Chiba Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail hkitahara@chiba-u.jp
Affiliation Chiba University Hospital