KCT0008880尚未招募Unknown
ENAVOgliflozin Outcome Trial in Patients with Severe Aortic Stenosis after Transcatheter Aortic Valve Replacemet
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 1,040
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
- •1. Patients aged =19 with symptomatic aortic stenosis who underwent successful Transcatheter aortic valve implantation (TAVI)* (either native valve or valve in valve with any approved/marketed device).
- •* A successful TAVI is defined as device success according to the VARC-2(Valve Academic Research Consortium 2) and VARC-3 criteria:
- •correct positioning of a single prosthetic heart valve into the proper anatomical location AND
- •intended performance of the prosthetic heart valve (mean aortic valve gradient <20 mmHg, peak velocity <3 m/s, no moderate or severe prosthetic valve regurgitation) AND
- •absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure).
- •2. Heart Failure with Mildly Reduced or Preserved Ejection Fraction
- •Left ventricular ejection fraction (LVEF) =40%
- •structural heart disease_Left ventricular hypertrophy (LVH) or Left atrial enlargement
- •A. Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness = 1.1 cm or
- •B. Left atrial (LA) enlargement with at least one of the following: LA width (diameter) =3.8 cm or LA length = 5.0 cm, or LA area = 20cm2, or LA volume = 55mL or LA volume index = 29mL/m.
- •NT-proBNP = 300 pg/mL (for patients without ongoing atrial fibrillation) or NT-proBNP must be = 600 pg/mL (for patients with ongoing atrial fibrillation).
- •3. Patients who voluntarily participated in the written agreement
排除标准
- •1. Receiving therapy with an SGLT2(Sodium-glucose Cotransporter 2) inhibitor within 4 weeks prior to randomization; discontinuation of an SGLT2 inhibitor or combined inhibitor of SGLT1 and SGLT2 inhibitor for the purposes of study enrolment is not permitted.
- •2. According to the judgment of the investigator, patients who are deemed unsuitable for participation in this clinical trial based on their condition (e.g., acute illnesses and major surgical procedures within the last three months).
- •3. Known allergy, hypersensitivity, or previous intolerance to SGLT2 inhibitors.
- •4. Left ventricular ejection fraction (LVEF) < 40%
- •5. Type I Diabetes Mellitus or diabetic ketoacidosis
- •6. Chronic cystitis and/or recurrent urinary tract infection (=2 times within 1 year).
- •7. Stroke or transient ischemic attack within 12 weeks prior to enrollment.
- •8. Symptomatic persistent hypotension and/or a systolic blood pressure (SBP) < 95 mm Hg at screening or at randomization.
- •9. SBP =180 mmHg irrespective of treatment or SBP =160 mmHg with at least =3 antihypertensive drugs at screening or randomization.
- •10. Heart failure due to any of the following: known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease.
- •11. Renal insufficiency (eGFR <30 ml/min/1.73 m2 of body-surface area) or requiring dialysis at the time of screening.
- •12. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices, coagulopathy) or moderate and severe liver failure (alanine transaminase (ALT) or aspartate transaminase (AST) > 2x normal upper limit.
- •13. Significant chronic pulmonary disease requiring home oxygen or primary pulmonary arterial hypertension.
- •14. Current or suspicious malignancy or history of malignancy within 5 years
- •15. Uncontrolled anaemia or haemoglobin <9g/dl
- •16. Uncontrolled hypothyroidism or arrhythmia or tachycardia
- •17. Current ongoing alcoholic or drug addict
- •18. Subjects with non-cardiac co-morbidities with life expectancy less than 12 months
- •19. Planned major high-risk operation after transcatheter aortic valve replacement (TAVR)
- •20. Women of childbearing age who have not reached a consensus on the use of highly effective contraception. Pregnancy or breastfeeding.
- •21. Participation in other clinical trials, However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
- •1)Participating in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
- •2)Screening failed before any interventional factor is involved.
- •3)Participants who have completed their involvement in clinical trials and have surpassed a 4-week period since their last administration of the investigational drug.
- •4)Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.
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