EUCTR2012-003219-77-DK进行中（未招募）1 期
Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure
Copenhagen University Hospital, Rigshospitalet0 个研究点目标入组 20 人开始时间: 2012年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age > 18 years
- •-LVEF < 45 %
- •-Treatment with beta-blockers and ACE-inhibitors for at least 1 month
- •-NYHA-class II-III
- •-Given informed consent
- •Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will provide a negative urine HCG before entering the study
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Signs of symptomatic or ongoing myocardial ischemia
- •-Presence of hypovolemic hyponatremia (as judged by the investigator)
- •-Clinical signs of volume depletion or dehydration
- •-Hypernatremia (P-Na+) > 145 mmol/L
- •-Chronic obstructive pulmonary disease (FEV1 < 1L)
- •-Supine systolic blood pressure < 85 mmHg
- •-Significant orthostatic hypotension
- •-standing blood pressure < 80 mmHg or a blood pressure drop > 20 mmHg when changing from a supine to a standing position
- •-Uncontrolled hypertension
- •-Uncontrolled cardiac arrhythmias
- •-Untreated serious hypothyroidism
- •-Adrenal insufficiency
- •-Poor echocardiographic window
- •-Not able to perform exercise testing
- •-Permanent atrial fibrillation or atrial fluttering
- •-Planned coronary by-pass surgery
- •-Moderate hepatic impairment (ALAT/ASAT > 3 UNL)
- •-Presence of other diseases affecting treatment with conivaptan or the evaluation of safety
- •-Severely decreased kidney function (eGFR < 20 ml/min)
- •-Serum K+< 3.5 or > 5.5 mmol/L
- •-Conivaptan intolerability
- •-Corn allergy
- •-Treatment with potent CYP3A-inhibitors (ketoconazole, otrakonazole, clarithromycin, ritonavir, indinavir)
- •-Treatment with arginine vasopressin, oxytocin, desmopressin and other medications for the treatment of hyponatremia (lithium salts, urea and demeocycline)
- •-Warfarin treatment
- •-Presence of infection or active bleeding
- •-Need of inotropic circulatory support within the last 30 days
- •-Pregnant women or fertile women not taking safe contraception
- •-Women who are breastfeeding
- •-Hemodynamically significant heart valve disease estimated by echocardiography
- •-The ability to understand written and oral Danish
- •-Contraindication to insertion of Swan-Ganz catheter
研究者
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