EUCTR2019-002558-21-CZ进行中（未招募）1 期
Aldose Reductase Inhibition for Stabilization of Exercise capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure) - ARISE-HF
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Type 2 Diabetes Mellitus (T2DM)
- •2. One of the following age-related criteria:
- •Age = 60 years OR
- •Age = 40 to < 60 years AND at least 1 of the following 2 risk factors:
- •o Duration of diabetes = 10 years
- •o eGFR < 60 mL/min/1.73 m2
- •3. Demonstration of DbCM/ Stage B Heart Failure defined by at least one of the following 3 criteria:
- •Echocardiographic demonstration of the following, as confirmed by either the central core lab or by local review at selected study centers:
- •- Left Ventricular Ejection Fraction (LVEF) >= 45%
- •- At least 1 of the following 5 abnormalities:
- •o Absolute value of Global longitudinal strain (GLS) < 16% (i.e., GLS >-16%)
- •o Left ventricular hypertrophy (LVH) defined as left ventricular mass index (LVMI) = 95 g/m2 in women and =115 g/m2 in men
- •o Left atrial enlargement (LAE) defined as left atrial volume index (LAVi) = 34 mL/m2
- •o Diastolic Dysfunction defined as E/E’ = 13
- •o Right ventricular systolic pressure (RVSP) > 35 mmHg
- •NT-proBNP = 50 pg/mL
- •HsTnT = 6 ng/L
- •4. CPET demonstration of both, as confirmed by the CPET core lab:
- •Impaired functional capacity, i.e., Peak VO2 < 75% of predicted, based on age and gender
- •Ability of maximal effort, i.e., achieve a RER =1.05
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 405
排除标准
- •1.Prior diagnosis of overt/symptomatic heart failure / stage C heart failure (SCHF), or prior or current symptom(s) or sign(s) that in the
- •opinion of the investigator may be related to undiagnosed overt/symptomatic heart failure / SCHF.
- •2. Any prior echocardiographic measurement indicating ejection fraction (EF) < 40%
- •3. History of acute coronary syndrome (ACS), including acute myocardial infarction
- •4. History or planned coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI; e.g., stent or angioplasty)
- •5. Prior diagnosis of coronary artery disease (CAD) defined as = 50% stenosis of any major coronary artery
- •6. History of severe mitral, aortic, tricuspid, or pulmonary valve disease, or moderate valve disease requiring intervention
- •7. History of any clinically significant arrhythmia (including permanent atrial fibrillation or history of paroxysmal atrial fibrillation requiring hospitalization, unless successfully ablated with no episodes of recurrence for at least 3 years)
- •8. History of stroke
- •9. History of congenital, infective, toxic (e.g., chemotherapy or radiation), infiltrative (e.g., amyloidosis, sarcoidosis, or hemochromatosis), post-partum, or hypertrophic cardiomyopathy
- •10. Myocarditis induced by active autoimmune disease (e.g., Graves’ disease or systemic lupus erythematosus)
- •11. Pulmonary arterial hypertension
- •12. Blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at screening, treated or untreated
- •13. History of multiple hospitalizations for hypertensive emergency
- •14. BMI > = 45 kg/m2
- •15. Antihyperglycemic treatment has not been stable in the 12 weeks prior to screening in the opinion of the Investigator
- •16. Treatment with inhibitors of the renin-angiotensin-aldosterone system has not been stable in the 12 weeks prior to screening in the opinion of the Investigator
- •17. Use of thiazolidinediones at screening and/or after randomization
- •18. Planned start of a SGLT2-inhibitor after randomization (If a decision to start a SGLT2-inhibitor has already been made during the screening
- •period, the treatment with a SGLT2-inhibitor should be initiated before randomization. Note that initiation of a SGLT2-inhibitor during the study
- •is allowed at any time before and after randomization.)
- •19. Any current or prior use of a loop diuretic
- •20. Pregnant or breastfeeding women
- •21. Females of childbearing potential not willing to use a highly effective form of birth control from screening until the Study Closeout Visit, or Post-Treatment Follow-up Visit, whichever occurs later
- •22. Severe disease making implementation of the protocol or interpretation of the study results difficult . This includes clinically significant hematopoietic, renal, hepatic, endocrine, pulmonary, neurological, psychiatric, immunological, dermatological, or gastrointestinal diseases or active malignant tumor as well as conditions that would impact the performance of a CPET.
- •23. Any condition that prevents the obtainment of a good quality echocardiogram at baseline
- •24. History of substance abuse including alcohol within 3 years
- •25. History of clinically significant drug hypersensitivity reactions
- •26. Severe lower extremity complications and/or history of non-traumatic amputations
- •27. Short life expectancy (<12 months) making implementation of the protocol or interpretation of the study results difficult.
- •28. Investigators, site personnel directly affiliated with this study, and their immediate families
- •29. Any other condition that, in
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