- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04490681
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Seok-Min Kang
- Telefonní číslo: 82-2-2228-8450
- E-mail: smkang@yuhs.ac
Studijní místa
-
-
-
Seoul, Korejská republika
- Severance Hospiatal
-
Kontakt:
- Seok-Min Kang
- Telefonní číslo: 82-2-2228-8450
- E-mail: smkang@yuhs.ac
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: placebo
Placebo
|
Placebo skupina
|
Experimentální: Ertugliflozin
Ertugliflozin 5mg
|
Fixed dose Ertugliflozin (5mg)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
Časové okno: Baseline
|
The ECV value change in MRI from baseline to End of trial (48 weeks)
|
Baseline
|
The ECV value change in CMR after Drug (Ertugliflozin or Placebo) administration
Časové okno: 48 Weeks after drug administration
|
The ECV value change in MRI from baseline to End of trial (48 weeks)
|
48 Weeks after drug administration
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
CMR parameters : ECV (%)
Časové okno: 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 (%)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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 (%)
Časové okno: 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 (%)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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 (%)
Časové okno: 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 (%)
Časové okno: 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 (%)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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