A multicenter, Double-blind, RandOmised, two arm Parallel group trial to determine the effects of torasemide versus furosemide on one marker (PIP) of cardiac fibrosis in patient with Diastolic Heart Failure and diabetes mellitus type II - DROP-PIP DHF

Charité Universitätsmedizin Berlin0 个研究点目标入组 35 人开始时间: 2013年11月12日最近更新: 2022年5月30日

适应症

试验速览

暂无简介。

•Signed, written informed consent
•Males or females
•Age = 18 years
•Diagnosed Diastolic Heart Failure according to the ESC guidelines (1)Signs or symptoms of heart failure, 2)Normal or mildly abnormal left ventricular ejection fraction (LVEF), 3)Evidence of diastolic left ventricular (LV) dysfunction)
•PIP = 110 ng/ml or PIP = 70 ng/ml if left atrial volume (LAV) > 29 ml/m²
•Diabetes type II
•Women of childbearing potential must test negative for pregnancy and must agree to use a highly effective contraceptive method (defined as pearl index < 1) during the trial period.
•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 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•Women during the lactation period, pregnant or of childbearing potential not using an effective contraceptive method
•Cardiac valve disease defined as regurgitation =grade 2
•Chronic dialysis
•Significant liver disease
•Malignant tumor
•Metabolic bone disease, autoimmune diseases or hyperthyroidism
•Prior documented intolerance to torasemide, furosemide, or sulfonylureas
•Known contraindications for torasemide or furosemide, especially hypovolemia, hypokalemia (<3,6 mmol/l), hyponatremia (< 135 mmol/l)
•Significant disorder of micturition
•Treatment with loop diuretics (e.g. torasemide, furosemide) at the time of baseline visit and throughout entire course of the trial. Patients with loop diuretics will undergo a washout of at least 5 (±2) days weeks after inclusion contact
•Treatment with mineralocorticoid receptor antagonists
•Changes in concomitant medication within the washout period
•Any patient characteristic that may interfere with compliance with the trial protocol, such as dementia, substance abuse, history of non-compliance with prescribed medications or medical appointments
•Concomitant participation in other clinical trials (Participation in another clinical trial within the last 30 days before enrollment)
•Missing willingness of the patient regarding storage and transfer of pseudonymized health data
•Patient is institutionalized because of legal or regulatory order (according to AMG § 40(1)

发起方