ALDOSTERONE RECEPTOR BLOCKADE IN DIASTOLIC HEART FAILUREA double-blind, randomised, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in patients with symptomatic diastolic heart failure - Aldo-DHF

Georg-August-Universität Göttingen0 个研究点目标入组 420 人开始时间: 2008年8月27日最近更新: 2012年9月18日

适应症

试验速览

暂无简介。

•· Current heart failure symptoms consistent with NYHA II or beyond
•· Left ventricular ejection fraction (LVEF) = 50% at rest
•· Sinus rhythm or atrial fibrillation
•· if sinus rhythm Echocardiographic parameters of diastolic dysfunction (Grade = I, see Appendix)
•· Peak VO2 = 25 ml/kg/min
•· Males and females of age = 50 years
•· Written informed consent of the patient
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients will be excluded for ANY ONE of the following reasons:
•· definite or probable pulmonary disease (VC<80% or FEV1<80% of reference values on spirometry)
•· severe obesity (BMI = 36 kg/m2)
•· psychological disorders with suspected interaction to study outcome
•· Prior documented intolerance to an aldosterone receptor antagonist
•· Prior documented systolic heart failure (LVEF = 40%)
•· Changes in concomitant medication within the last two weeks prior screening visit
•· Significant coronary artery disease (current angina pectoris or ischemia on stress tests; untreated coronary stenosis >50%; Myocardial infarction or CABAG within the last 3 months)
•· Known contraindications for spironolactone
•· Significant laboratory abnormalities (potassium = 5.1 mmol/L; hemoglobin = 11g/dL, hematocrit = 33%)
•· Significant renal dysfunction (creatinine > 1.8 mg/dL or eGFR < 30 mL/min/1,73m²)
•· Concomitant therapy with a potassium-sparing diuretic (e.g., triamterene, amiloride), potassium substitution, or high-dose acetylsalicylic acid (>500 mg/d) or permanent intake of non-steroidal antiphlogistic agents
•· Insulin-dependent diabetes mellitus with a history of ketoacidosis
•· Significant hypotension (blood pressure < 90 mmHg systolic and/or 50 mmHg diastolic)
•· Pregnant or nursing women
•· Women with child bearing potency without effective contraception (i.e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner)

发起方