KCT0009339尚未招募Unknown
The Efficacy of Enavogliflozin on Exercise Performance and Diastolic Function in Heart Failure with Preserved Ejection Fraction: A Randomized Controlled Trial (ENRICH-PEF)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 154
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •[Inclusion Criteria]
- •(1) 19 years of age or older
- •(2)NYHA Class II-? Dyspnea
- •(3)HFpEF diagnosis (irrespective of time from diagnosis)3
- •?Noninvasive
- •i.LVEF =50%
- •ii.NT-proBNP =220 pg/mL or BNP =80 pg/mL if in sinus rhythm
- •NT-proBNP =660 pg/mL or BNP =240 pg/mL if in atrial fibrillation (AF)
- •iii.Echocardiography with at least one of the following criteria:
- •-LAVI =34 ml/m2 if AF
- •-Lateral E/e' =9
- •-LVMI (left ventricular mass index) =115 g/m2 if male or =95 g/m2 if female
- •-LV (left ventricular) wall thickness =12mm
- •?Invasive: LVEDP =16 mmHg or PCWP =15mmHg
- •(4)Stable/chronic ambulatory patients without hospitalization within the last 30 days due to heart failure decompensation episode
- •(5) If a heart failure-related drug is being administered, a person is being administered stably without changing the dose for at least 3 weeks prior to randomization
排除标准
- •[Exclusion Criteria]
- •(1) The procedures described in this protocol are not desired or impossible
- •(2) If walking ability is limited due to joint disease, other motor dysfunction, or lung disease other than cardiopulmonary fitness
- •(3) New York Heart Association (NYHA) Class IV Person
- •(4) Type 1 diabetes
- •(5) eGFR <60 ml/min/1.73m2 (according to CKD-EPI formula)
- •(6) (6) Hb<7g/dL
- •(7) Severe liver damage (Child-Pugh class C)
- •(8) Acute myocardial infarction (Acute MI), Unstable angina (Unstable angina) within 30 days of study selection, or coronal revascularization scheduled for study selection
- •(9) Serious left heart valve disease (moderate to severe stenosis and severe regurgitation)
- •(10) Heart failure due to any of the following: invasive cardiomyopathy (amyloidosis, sarcoidosis), active myocarditis (active myocarditis), constrictive pericarditis, hypertrophic cardiomyopathy
- •(11) Low blood pressure with symptoms (systolic blood pressure <90mmHg)
- •(12) Severe chronic obstructive pulmonary disease (postbronchodilator FEV1/FVC <70% and FEV1 <50%)
- •(13) If treated with SGLT2 inhibitor within 30 days of selection of study subject
- •(14) If you have a history of diabetic ketoacidosis during treatment with SGLT2 inhibitors
- •(15) Current history or history of recurrent urinary tract and genital infection
- •(16) Patients with a history of hypersensitivity reactions to SGLT2 inhibitors
- •(17) If the survival period is within two years due to a comorbid condition other than heart disease, or if it is deemed difficult to comply with the protocol due to alcohol or substance abuse, etc., (according to medical judgment of the field investigator)
- •(18) Female patients who are currently pregnant or plan to become pregnant
- •(19) Female patients who are breastfeeding or plan to breastfeed
- •(20) Participating in other clinical trials
研究者
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