NL-OMON53498尚未招募2 期
Evaluation of GeranylGeranylAcetone in heart failure with preserved ejection fraction - GLADIATOR-HFpEF
Amsterdam UMC0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
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
- 18 至 99（—）
入选标准
- •To be eligible to participate in this study, a subject must meet all of the
- •following criteria:
- •1. Age>= 50 years
- •2. Patients with a diagnosis of symptomatic chronic heart failure (New York
- •Heart Association class II or III) AND preserved systolic LV function (LV
- •ejection fraction or LVEF >= 50%) documented within the last 6 months AND
- •evidence of diastolic LV dysfunction with at least 1 out of the following 4
- •- HFA-PEFF score >=5
- •- H2FPEF score >=6
- •- HFpEF according to the 2021 ESC HF Guidelines (NT-proBNP>125 pg/ml AND either
- •LV mass indexed or LVMI >95 g/m2 for women and >115 g/m2 for men OR left atrial
- •volume indexed or LAVI >34 ml/m2 OR mean e; septal/lateral < 9 cm/s) OR E/e*
- •>13) OR TR velocity at rest > 2.8 m/s.
- •- Pulmonary capillary wedge pressure (PCWP) >15 mmHg and/or >25 mmHg during
排除标准
- •1. Current acute decompensated heart failure, requiring hospitalization or
- •augmented therapy with intravenous diuretics, vasodilators, and/or inotropic
- •2. Acute coronary syndrome, transient ischemic attack/cerebrovascular accident,
- •major surgery within the previous 3 months
- •3. Hemoglobin <9 g/dl at screening
- •4. LVEF <40% measured at any time point in the history of the patient
- •5. History of mitral valve repair or replacement
- •6. Presence of significant valvular disease defined as mitral valve
- •regurgitation defined as grade >= 3+ MR; tricuspid valve regurgitation defined
- •as grade >= 2+ TR; aortic valve disease defined as >= 2+ AR or > moderate AS
- •7. Acute myocarditis within 3 months prior to randomization
- •8. Infiltrative cardiomyopathy
- •9. Genetic cardiomyopathy
- •10. Severe pulmonary disease requiring home oxygen or chronic oral steroid
- •11. Precapillary pulmonary hypertension
- •12. BMI >40 kg/m2
- •13. Estimated glomerular filtration rate (GFR) <20 ml/min or >90 ml/min
- •14. History of solid organ transplantation including kidney transplantation
- •15. Atrial fibrillation or atrial flutter with resting ventricular rate >110 bpm
- •16. Not able to undergo the complete study protocol
- •17. Doubt about compliance
- •18. Pre-menopausal women who are nursing, pregnant, or of child-bearing
- •potential and not practicing an acceptable method of birth control
- •19. Chronic absorption problems
- •20. Proven allergy for lactose products or cow-milk.
- •21. Proven allergy for Iodide-containing contrast, Iohexol or PAH.
- •22. Any documented or suspected malignancy or history of malignancy within 1
- •year prior to screening, except appropriately treated basal cell carcinoma of
- •the skin or in situ carcinoma of the cervix
- •23. Currently enrolled in another investigational device or drug trial
- •24. Estimated life expectancy <1 year
研究者
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