ISRCTN47533126已完成未知
A double-blinded cross-over clinical trial investigating hemodynamic effects of exenatide on diabetic patients hospitalized for congestive heart failure
Stockholm South General Hospital (Södersjukhuset AB) (Sweden)0 个研究点目标入组 20 人开始时间: 2011年8月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 性别
- All
入选标准
- •1. Type 2 diabetes patients with LVHF and NYHA class III or IV symptoms of heart failure who are admitted to the hospital for management of decompensated chronic heart failure
- •2. A stable period of 24 hours using established therapy, i.e. ACE/ARB-inhibitors, beta-blockers, aldosterone-inhibitors and diuretics
- •3. Patients who are monitored with a pulmonary artery catheter for clinical purposes
- •4. In subjects without known diabetes, diabetes will be confirmed by at least two fasting plasma glucose levels exceeding 7 mmol/l or a random plasmaglucose exceeding 11,0 mmol/l according to the American Diabetes Association definition of diabetes
- •5. Male and female subjects
- •6. 18-80 years of age
排除标准
- •1. Type 1 diabetes (autoantibody positive)
- •2. Need of inotropic agents, nitroglycerin-infusion or aortic balloon device
- •3. Unstable LVHF despite maximal oral treatments and i.v. diuretics
- •4. Significant ischemic heart disease (defined as angina-limited exercise or unstable angina); documented acute myocardial infarction (MI) within the previous 8 weeks
- •5. Active myocarditis; malfunctioning artificial heart valve
- •6. Symptomatic primary pulmonary disease; serious arrhythmias, defined as a history of ventricular flutter or fibrillation other than that occurring within 24 hours after acute MI
- •7. History of sudden cardiac death or symptomatic ventricular tachycardia within 3 months before study entry; second or third degree atrioventricular block, unless the patient has a functioning implanted pacemaker
- •8. Supine systolic blood pressure <85 mm Hg or >200 mm Hg
- •9. Primary renal impairment (creatinine clearance < 30 ml/min)
- •10. Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/l or >5.5 mmol/l)
- •11. Significant anemia (Hb < 90 g/l), or treatment with another investigational agent within 30 days before study entry
- •12. Severe gastrointestinal disease, including gastroparesis
- •13. Pregnancy or lactation
- •14. History of drug abuse
- •15. Presence or history of allergic reaction or intolerance to multiple drugs
- •16. Subjects considered by the Investigator as unsuitable candidates to receive an investigational drug
- •17. Known history of, or concomitant medical condition that might interfere with the evaluation of study medication
- •18. No minor subjects (<18 years of age) or pregnant women will be participating in the study
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