Status:
UNKNOWN
Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)
Lead Sponsor:
Yonsei University
Conditions:
Heart Failure With Nonischemic Cardiomyopathy
Eligibility:
All Genders
19-74 years
Phase:
PHASE3
Brief 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 (S...
Detailed Description
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 myoca...
Eligibility Criteria
Inclusion
- 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
- 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 cardiac resynchronization therapy
- Symptomatic hypotension and/or a SBP \< 95 mmHg at screening
- Estimated GFR \< 30 mL/min/1.73m2
- History of ketoacidosis
- Symptomatic peripheral artery disease and history of lower limb amputation
- Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt.
- History of severe pulmonary disease
- Significant mitral \& aortic valve disease (e.g. moderate to severe, severe degree)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method
- Pregnant or nursing (lactating) women
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04490681
Start Date
August 1 2020
End Date
December 1 2022
Last Update
August 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Severance Hospiatal
Seoul, South Korea