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) studied | Aortic stenosis |
| Date of first enrollment | 22/09/2022 |
| Target sample size | 84 |
| Countries of recruitment | |
| Study type | Interventional |
| 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. Two days 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 Outcome | NT-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 maximum | Not applicable |
| Gender | Both |
| Include 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). |
| Exclude criteria | 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 |
Related Information
| Primary Sponsor | Kitahara Hideki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Clinical Research Initiation Fund of Chiba University Hospital |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hideki Kitahara |
| Address | 1-8-1 Inohana Chuo-ku, Chiba Chiba Japan 260-8677 |
| Telephone | +81-43-222-7171 |
| 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 |
| hkitahara@chiba-u.jp | |
| Affiliation | Chiba University Hospital |