Heart Failure With Nonischemic Cardiomyopathy Clinical Trial
Official title:
Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)
Based on recent studies demonstrating SGLT2 inhibitors' favorable effects on cardiovascular
outcomes especially for heart failure, the investigators hypothesize that sodium-glucose
co-transporter-2 (SGLT2) inhibitor, ertugliflozin, is effective on reducing cardiac fibrosis
in patients with nonischemic cardiomyopathy so the investigators try to examine this
hypothesis in a single-center, double-blind, randomized controlled study using cardiac
magnetic resonance (CMR).
This study is a prospective, single-center, randomized, double-blind, two arm parallel group,
placebo-controlled clinical trial involving patients with nonischemic cardiomyopathy.
Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to
ertugliflozin or placebo therapy, and cardiovascular functional assessment and clinical event
follow-up will be undertaken.
Subjects : Patients with non-ischemic cardiomyopathy who need medical treatment Procedures : This is a prospective, randomized trial to compare cardiopulmonary motor tests, cardiac MRI including myocardial fibrosis parameters (ECV, etc.), and incidence of various heart failure-related cardiovascular events during the follow-up period between patients with ertugliflozin drug therapy and placebo drug. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 to ertugliflozin (5mg) or placebo therapy. Randomization will be stratified according to presence of diabetes mellitus, and the upper limit of randomized non-DM patients will be set as 36 patients (70%). The estimated enrollment period is 18 months (n=52) and all patients will be followed for 12 months after randomization. Random assignment is performed at random assignment visit (V1) through eCASE web system and following study procedures will be conducted according to the randomization. CMR, Cardiopulmonary exercise test, serum biomarkers, and clinical endpoints will be measured at 3,6,12 months. ;