Study to evaluate the safety and efficacy of sacubitril valsartan under hemodialysis

JRCT ID: jRCT1031230599

Registered date:26/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic heart failure
• Date of first enrollment: 26/01/2024
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Sacubitril valsartan should be administered orally twice daily with a starting dose of 50 mg twice daily. If tolerated, the dose may be increased stepwise to 200 mg twice daily at 2- to 4-week intervals, in single doses of 50 mg, 100 mg, or 200 mg. The dose may be reduced according to tolerability.

Outcome(s)

• Primary Outcome: Serious adverse events associated with sacubitril valsartan administration

Secondary Outcome

Left ventricular ejection fraction (LVEF) at 3 and 6 months after treatment with sacubitril valsartan
Brain natriuretic peptide (BNP) and N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) at 3 and 6 months after treatment with sacubitril valsartan
Hyperkalemia (serum K level of 5.5 mEq/L or higher)
Abnormal elevation of liver enzymes (AST or ALT > 100 IU/L)
Angioedema
Hypotension (systolic blood pressure less than 95mmHg) with loss of consciousness (shock)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Japanese patients 18 years of age or older at the time of consent
2) Patients undergoing hemodialysis
3) Patients with a pre-dialysis hemoglobin concentration of 8.0 g/dL or higher
4) Patients diagnosed with New York Heart Association (NYHA) cardiac function class I-III chronic heart failure and left ventricular ejection fraction less than 50%
5) Patients who have received a thorough explanation of the study and who have given written consent of their own free will after full understanding of the study

Exclude criteria

1) Patients with acute noncompensated heart failure (exacerbation of chronic heart failure with obvious signs and symptoms that require intravenous administration of drugs for heart failure)
2) Patients with a history of angioedema (angioedema caused by angiotensin II receptor blockers or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.)
3) Patients receiving angiotensin-converting enzyme inhibitors or within 36 hours of discontinuation of angiotensin-converting enzyme inhibitors
4) Patients with symptomatic hypotension
5) Diabetic patients receiving aliskiren fumarate
6) Patients with severe anemia (received blood transfusion within 4 weeks prior to obtaining consent)
7) Patients with severe hepatic dysfunction (Child-Pugh classification C or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 100 IU/L)
8) Patients with cerebrovascular disease
9) Patients with hyperkalemia (serum K level of 5.5 mEq/L or higher) in the past 3 months
10) Patients with a history of severe allergy to drugs
11) Patients with drug or alcohol addiction or with a history of drug or alcohol addiction
12) Patients who have received sacubitril valsartan sodium hydrate in the past
13) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating
14) Other patients whom the investigator or sub-investigator determines to be unsuitable for the safe conduct of this study

Related Information

• Primary Sponsor: Asanuma Katsuhiko
• Source(s) of Monetary Support: Chiba University Hospital