NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1041210066

Registered date:09/09/2021

SAVE-HF

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic heart failure
Date of first enrollment04/10/2021
Target sample size66
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)To divide HFrEF patients into sacubitril/valsartan or control group and to evaluate the impacts of 9 months of sacubitril/valsartan on myocardial myocardial tissue and LV morphology in HFrEF.

Outcome(s)

Primary OutcomeThe change in extracellular volume fraction (ECV) measured by cardiac MRI before and after 9 months of sacubitril/valsartan treatment
Secondary Outcome(1) the change in EF, LV volumes and mass, the rate of change in ECV (2) LV longitudinal global strain, the rate of chages in LV volumes and mass, and myocardial blood flow (3) changes in biomarkers of LV remodelling: soluble suppression of tumourigenicity-2 (ST2), galectin-3, change in neurohormonal levels: NT-proBNP, BNP, ANP, Troponin I (4) change in NYHA functional class and physical function (5) Kansas City Cardiomyopathy Questionnaire score (6) Physical function by maximal cardiopulmonary tests (7) 24-hour ABPM (8) presence or absence of gender differences in the LV remodeling pattern

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include 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
Exclude 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

Related Information

Contact

Public contact
Name Kaoru Dohi
Address 2-174 Edobashi, Tsu 514-8507, Japan Mie Japan 514-8507
Telephone +81-59-231-5015
E-mail dohik@med.mie-u.ac.jp
Affiliation Mie University Graduate School of Medicine
Scientific contact
Name Kaoru Dohi
Address 2-174 Edobashi, Tsu 514-8507, Japan Mie Japan 514-8507
Telephone +81-59-231-5015
E-mail dohik@med.mie-u.ac.jp
Affiliation Mie University Graduate School of Medicine