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.
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Seok-Min Kang
- 电话号码:82-2-2228-8450
- 邮箱:smkang@yuhs.ac
学习地点
-
-
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Seoul、大韩民国
- Severance Hospiatal
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接触:
- Seok-Min Kang
- 电话号码:82-2-2228-8450
- 邮箱:smkang@yuhs.ac
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
|
安慰剂组
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实验性的:Ertugliflozin
Ertugliflozin 5mg
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Fixed dose Ertugliflozin (5mg)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
大体时间:Baseline
|
The ECV value change in MRI from baseline to End of trial (48 weeks)
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Baseline
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The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
大体时间:48 Weeks after drug administration
|
The ECV value change in MRI from baseline to End of trial (48 weeks)
|
48 Weeks after drug administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
CMR parameters : ECV (%)
大体时间:baseline
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
baseline
|
CMR parameters : ECV (%)
大体时间:12 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
12 weeks after drug administration
|
CMR parameters : ECV (%)
大体时间:48 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
48 weeks after drug administration
|
CMR parameters : Native T1 (ms)
大体时间:baseline
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
baseline
|
CMR parameters : Native T1 (ms)
大体时间:12 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
12 weeks after drug administration
|
CMR parameters : Native T1 (ms)
大体时间:48 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
48 weeks after drug administration
|
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
大体时间:Baseline
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
Baseline
|
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
大体时间:12 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
12 weeks after drug administration
|
CMR parameters : left & right ventricular (LV & RV) mass index (g/m2)
大体时间:48 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
48 weeks after drug administration
|
CMR parameters : LV & RV ejection fraction (%)
大体时间:Baseline
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
Baseline
|
CMR parameters : LV & RV ejection fraction (%)
大体时间:12 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
12 weeks after drug administration
|
CMR parameters : LV & RV ejection fraction (%)
大体时间:48 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
48 weeks after drug administration
|
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
大体时间:Baseline
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
Baseline
|
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
大体时间:12 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
12 weeks after drug administration
|
CMR parameters : LV & RV end-systolic volume, LV & RV end-diastolic volume (ml)
大体时间:48 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
48 weeks after drug administration
|
CMR parameters : cine-base cardiac strain (%)
大体时间:Baseline
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
Baseline
|
CMR parameters : cine-base cardiac strain (%)
大体时间:12 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
12 weeks after drug administration
|
CMR parameters : cine-base cardiac strain (%)
大体时间:48 weeks after drug administration
|
CMR parameters : the changes of myocardial fibrosis markers (ECV, Native T1), ventricular muscle mass marker (left & right ventricular (LV & RV) mass index), ventricular functional markers (LV & RV ejection fraction, cine-base cardiac strain), and ventricular remodeling markers (LV & RV end-systolic volume, LV & RV end-diastolic volume).
These parameters represent myocardial fibrotic change, ventricular remodelling, systolic function.
|
48 weeks after drug administration
|
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
大体时间:baseline
|
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
|
baseline
|
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
大体时间:12 weeks after drug administration
|
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
|
12 weeks after drug administration
|
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
大体时间:24 weeks after drug administration
|
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
|
24 weeks after drug administration
|
Biomarkers : NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7
大体时间:48 weeks after drug administration
|
The change in degree of NT-proBNP, hsTn, soluble ST2, galectin-3, IGFBP7 after drug administration.
|
48 weeks after drug administration
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的