SAVE-HF

Effect of Sacubitril/valsartan on Left Ventricular Extracellular Volume in Heart Failure With Reduced Ejection Fraction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041210066

Enrollment

Registered

2021-09-09

Start date

2021-10-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure heart failure, heart failure with reduced ejection fraction (HFrEF), sacubitril/valsartan

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) patients with HF symptoms (NYHA class I-III) (2) patients with echo or MRI LVEF 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

Exclusion criteria: (1) patients with symptomatic hypotension and/or systolic blood pressure 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

Design outcomes

Primary

Measure	Time frame
The change in extracellular volume fraction (ECV) measured by cardiac MRI before and after 9 months of sacubitril/valsartan treatment	—

Secondary

Measure	Time frame
(1) the change in EF, LV volumes and mass, the rate of change in ECV (2) epicardial fat mass, subcutaneous fat, intrahepatic fat, liver T1 value, LV longitudinal global strain, RV strain, left atrial volume, atrial strain, the rate of chages in LV volumes and mass, and myocardial blood flow, concentricity index (3) changes in biomarkers of LV remodelling: galectin-3, soluble suppression of tumourigenicity-2 (ST2), U-cGMP, 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	—

Measure

Time frame

(1) the change in EF, LV volumes and mass, the rate of change in ECV (2) epicardial fat mass, subcutaneous fat, intrahepatic fat, liver T1 value, LV longitudinal global strain, RV strain, left atrial volume, atrial strain, the rate of chages in LV volumes and mass, and myocardial blood flow, concentricity index (3) changes in biomarkers of LV remodelling: galectin-3, soluble suppression of tumourigenicity-2 (ST2), U-cGMP, 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

—

Contacts

Public ContactKaoru Dohi

Mie University Graduate School of Medicine

dohik@med.mie-u.ac.jp+81-59-231-5015

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026