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.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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-
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Seoul、大韓民国
- Severance Hospiatal
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:プラセボ
|
プラセボ群
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実験的:Ertugliflozin
Ertugliflozin 5mg
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Fixed dose Ertugliflozin (5mg)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
時間枠:Baseline
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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
時間枠:48 Weeks after drug administration
|
The ECV value change in MRI from baseline to End of trial (48 weeks)
|
48 Weeks after drug administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
CMR parameters : ECV (%)
時間枠: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 (%)
時間枠: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 (%)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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 (%)
時間枠: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 (%)
時間枠: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 (%)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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 (%)
時間枠: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 (%)
時間枠: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 (%)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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プラセボの臨床試験
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Palacky University完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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University Hospital, Strasbourg, France積極的、募集していない