EUCTR2015-000410-22-DK进行中（未招募）1 期
Influence of liraglutide on diastolic cardiac function and myocardial perfusion as determined by magnetic resonance imaging in patients with type 2 diabetes: a double-blind randomized parallel-group trial
The Cardiovascular MR Group, Dept. 2011, Rigshospitalet0 个研究点目标入组 40 人开始时间: 2015年6月30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
- 40
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
- •Male or female patient fully capable of informed consent
- •Informed consent
- •Age 18-80 years (both years inclusive)
- •T2DM diagnosed at least 3 months
- •NYHA class I-III
- •E/e* = 9 or e* (lateral) =10 cm/sec, or both
- •LVEF > 50%
- •LVEDV/BSA < 97 ml/m2
- •Stable on heart medication for 6 weeks prior to randomization
- •Stable on antidiabetic treatment for 30 days prior to randomization
- •T2DM must be either treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Lack of consent.
- •NYHA class IV
- •Type 1 diabetes mellitus
- •Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomization
- •Glitazon therapy within 30 days prior to randomization
- •Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg
- •Supine systolic blood pressure <85 mmHg
- •Significant valvular heart disease
- •Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
- •Myocardial infarction, unstable angina, angina on exertion (=CCS class 2) or coronary revascularization within 3 months prior to randomization
- •Hospitalisation due to incompensated heart disease within 30 days to randomization
- •HbA1c >10%
- •eGFR< 60 ml/min/1,73 m2
- •Liver disease with aspartate aminotransferase/alanine aminotransferase >3 times upper limit of normal
- •Hypokalaemia (P-potassium <3.5 mmol/L) or hyperkalaemia (P-potassium >5.5 mmol/L)
- •Anaemia (haemoglobin <6.5 mmol/L)
- •Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
- •Prolonged use (> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to the beginning of the trail
- •Women of childbearing potential who are not on acceptable contraception
- •Pregnant or breastfeeding women
- •Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for = 5 years
- •Alcohol/drug abuse
- •Chronic or previous acute pancreatitis
- •History of thyroid adenoma or carcinoma
- •Inflammatory bowel disease
- •Clinical signs of diabetic gastroparesis
- •ICD/pacemaker or other contraindications to MRI scan
- •Severe claustrophobia
- •Atrial fibrillation
- •Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia at rest, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
- •Known or suspected hypersensitivity to trial product or related products
- •Current participation in any other clinical intervention trial
- •Receipt of an investigational drug with 30 days prior to the beginning of the trail
- •Other concominant disease or treatment that according to investigator’s assessment makes the patient unsuitable for participation in the study
研究者
相似试验
已完成
4 期
Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes PatientsDiabetes Mellitus Type 2Diastolic DysfunctionCardiac MRIMyocardial PerfusionNCT02655770Rigshospitalet, Denmark40
进行中（未招募）
1 期
Comparing the effects of two new therapies for diabetes on the heart, measures of fat and diabetes in young people with type 2 diabetesType 2 Diabetes MellitusEUCTR2012-002422-78-GBniversity of Leicester90
进行中（未招募）
不适用
Effect of Liraglutide on metabolism and function of the left ventricle in patients with type 2 diabetes and heart problems: study with RMN investigationsEUCTR2011-001408-37-ITFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
进行中（未招募）
1 期
Effekt von Linagliptin auf die myokardiale diastolische Dysfunktion in Patienten mit Diabetes mellitus Typ 2EUCTR2012-003858-81-DERWTH Aachen, Medizinische Fakultät60
进行中（未招募）
1 期
The Effect of Dulaglutide on Major Cardiovascular Events inPatients with Type 2 Diabetes: Researching CardiovascularEvents with a Weekly INcretin in Diabetes (REWIND) - REWINDCardiovascular events in patients with Type 2 diabetesMedDRA version: 20.0Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularSystem Organ Class: 100000004860EUCTR2010-023799-21-HUEli Lilly and Company9,901