SAVE-HF

Not Applicable

• Conditions: Chronic heart failure; heart failure, heart failure with reduced ejection fraction (HFrEF), sacubitril/valsartan; D006333

• Registration Number: JPRN-jRCT1041210066
• Lead Sponsor: Dohi Kaoru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

(1) patients with HF symptoms (NYHA class I-III)
(2) patients with echo or MRI LVEF<50% measured within last 3 months
(3) patients treated with up-titration of heart failure medications for at least 4 weeks
(4) patients with BNP level > or =18.4pg/ml or NT-pro BNP level > or =100 pg/ml within last 3 months
(5) patients aged > or = 20 years
(6) Japanese
(7) patients who are able to give informed consent

Exclusion Criteria

(1) patients with symptomatic hypotension and/or systolic blood pressure <90 mmHg
(2) patients with eGFR <30 mL/min/1.73m2
(3) patients with acute coronary syndrome, stroke, cardiovascular surgery, carotid artery surgery, other major cardiac surgery, or percutaneous coronary intervention within last 3 months
(4) patients with hospitalization due to heart failure within last 6 months
(5) patients with persistent/permanent atrial fibrillation
(6) patients with implantable cardiac devices
(7) patients with diagnosed or suspected cardiac amyloidosis
(8) patients with severe valvular heart disease except for severe functional mitral regurgitation
(9) patients with serum potassium >5.2 mmol/L
(10) patients with histories of angioedema
(11) patients with hypersensitivity or allergy to heart failure medications
(12) patients with unstable angina
(13) patients with liver dysfunction (AST or ALT 100 IU/L or more)
(14) patients with pregnancy or suspected pregnancy or patients with breast-feeding
(15) patients enrolled in a separate clinical trial or study within the past 3 months
(16) patients who are not eligible to participate in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified