The efficacy of angiotensin receptor neprilysin inhibitor in patients after transcatheter aortic valve implantation.
- Conditions
- Aortic stenosis
- Registration Number
- JPRN-jRCT1031220344
- Lead Sponsor
- Kitahara Hideki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method T-proBNP value at 6 months follow-up.
- Secondary Outcome Measures
Name Time Method [Efficacy]<br>Change in NT-proBNP value at 6 months follow-up<br>Systolic pulmonary artery pressure at 6 months follow-up<br>Edema scale at 6 months follow-up<br>NYHA class at 6 months follow-up<br>Increas or decrease in diuretics<br>Change in body weight<br>Cardiovascular events (death, admission for heart failure, myocardial infarction, etc.)<br>[Safety]<br>Incidence of adverse events<br>Prevalence of patients with serum K >5.5 mEq/L<br>Prevalence of patients with symptomatic hypotension