JPRN-jRCTs071230020尚未招募Unknown
The Impact of Empagliflozin on Left Ventricular Myocardial Stiffness in Heart Failure with Preserved Ejection Fraction - EMPA PV-loop study
Hieda Michinari0 个研究点目标入组 38 人开始时间: 2023年6月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Persons who have given written consent of their own free will
- •2) Age 40 years or older at the time of obtaining consent, regardless of gender
- •3) Patients diagnosed with HFpEF (NYHA 1-3) with clinical symptoms of heart failure (fatigue, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, leg edema) plus evidence of left ventricular ejection fraction over 50 percent, elevated left ventricular filling pressure (E/e' >14), and elevated plasma NT-proBNP (> 125 pg/mL).
排除标准
- •1) Patients with a history of cardiomyopathy (dilated cardiomyopathy or hypertrophic cardiomyopathy)
- •2) Patients with a history of cardiac amyloidosis
- •3) Patients with a history of cardiac sarcoidosis
- •4) Patients with early onset of acute myocardial infarction or unstable angina pectoris
- •5) Patients with constrictive pericarditis
- •6) Patients with cardiogenic shock
- •7) Patients with severe hepatic dysfunction (AST > 10 times)
- •8) Patients with moderate or severe valvular heart disease
- •9) Patients with uncontrolled arrhythmia (atrial fibrillation, frequent extrasystoles, ventricular tachycardia, ventricular fibrillation)
- •10) Patients with severe renal dysfunction (eGFR < 30 ml/min/1.73 m2) and patients on dialysis
- •11) Patients with a history of type 1 diabetes mellitus (including a history of ketoasdosis and diabetic foot)
- •12) Patients with a history of ketoacidosis
- •13) Patients with a history of diabetic foot
- •14) Patients with a history of coagulation abnormalities
- •15) Patients with symptomatic hypotension (systolic blood pressure <100 mmHg prior to randomization)
- •16) Patients with a history of peripheral arterial disease
- •17) Patients with pulmonary diseases such as COPD and interstitial pneumonia
- •18) Patients with active infectious diseases
- •19) Patients with a life expectancy of less than 1 year due to malignancy
- •20) Patients who cannot walk or cycle
- •21) Obese patients with BMI > 35 kg/m2
- •22) Patients with a history of hypersensitivity to SGLT2 inhibitors
- •23) Pregnant or lactating women
- •23) Patients who have difficulty administering the research drug through the prescribed route of administration
- •25) Patients who are unsuitable for cardiac catheterization
- •26) Patients who are deemed inappropriate for inclusion in the study by the principal investigator
研究者
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