Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Para… (NCT04490681) | Clinical Trial Compass
UnknownPhase 3
Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)
South Korea52 participantsStarted 2020-08
Plain-language summary
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.
Who can participate
Age range19 Years – 74 Years
SexALL
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Inclusion Criteria:
* Patients must agree to the study protocol and provide written informed consent
* Outpatients ≥ 19 years, \<75 years of age, male or female
* Non-diabetic or type 2 DM patients with HbA1c 7.0-10.5%
* Patients with nonischemic cardiomyopathy (LVEF ≤40%)
* Exclusion of ischemic origin cardiomyopathy using coronary angiography or CT angiography or SPECT scan (e.g. significant stenosis of proximal LAD or left main \& myocardial infarction)
* Dyspnea of NYHA functional class II or III
* NT-proBNP ≥ 400 pg/ml (≥ 900 pg/ml if atrial fibrillation or atrial flutter)
* Titration of HF medications should be completed and patients must take a stable, optimized dose of a β-blocker and an ACE inhibitor (or ARB or ARNI if indicated) for at least 4 weeks prior to study entry
Exclusion Criteria:
* History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, or SGLT-2 as well as known or suspected contraindications to the study drug
* Current use or prior use of a SGLT-2 inhibitor or combined SGLT-1 and 2 inhibitor
* Known history of angioedema
* Current acute decompensated heart failure or dyspnea of NYHA functional class IV
* Medical history of hospitalization within 6 weeks
* Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months
* Substantial myocardial ischemia requiring coronary revascularization therapy or a plan of coronary revascularization within 6 months
* A plan of heart transplantation or implantation of cardi…
What they're measuring
1
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
Timeframe: Baseline
2
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration