SOdium-glucose CO-transporter inhibition in patients with Type 2 Diabetes and Ischemic Heart Failure (SOCODIHF) - SOCODIHF

Karolinska Institutet Stockholm, Sweden0 个研究点目标入组 60 人开始时间: 2016年2月16日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•1. Age = 18 years
•2. Known T2DM (according to current WHO criteria) with HbA1c 48-86 mmol/mol (DCCT 5.6-10%; [57]).
•3. Chronic HF of ischemic origin (established according to current European Guidelines; Ischemic etiology defined as history of myocardial infarction given by typical ECG-changes (Q-wave or LBBB), previous PCI or CABG, symptoms typical of angina pectoris with coronary artery disease verified by an exercise test, non-invasive imaging or coronary angiography, since at least two months [58].
•4. Signed informed consent to trial participation consistent with ICH-GCP guidelines and local legislations
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 50

•1. Age > 75 years
•2. Contraindications to magnetic resonance imaging
•a) Implanted devices such as pacemaker or implantable cardioverter defibrillator
•b) Severe claustrophobia
•3. Serum creatinine estimated glomerular filtration rate < 30 ml/min/1.73m2
•4. Intolerance or contraindications to iv adenosine infusion, including clinically important asthma Patients with chronic obstructive pulmonary disease (COPD) should have a lung function test with reversibility testing performed within 12 month before study inclusion. The patient can be included if FEV1.0 is >60% of expected normal value and the reversibility test result should be <10% of the initial FEV1.0 value.
•5. Patients with severe concomitant disease (i.e. malignancy, liver failure) or chronic HF due to valvular disorders.
•6. Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: problems to self-monitor glucose, linguistic problems, resident outside of the catchment area, alcohol or drug abuse, psychiatric disorder)
•7. Planned for intervention with at discharge are planned for Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention or cardiac device treatment

发起方

Karolinska Institutet Stockholm, Sweden