Does Dapaglifozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes? - DAPA-LVH Trial

niversity of Dundee & NHS Tayside0 个研究点目标入组 66 人开始时间: 2019年5月1日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1.Provision of informed consent before any trial specific procedures.
•2.Diagnosed with type 2 diabetes mellitus based on the current American Diabetes Association guidelines.
•3.Aged >18 and <80 years
•4.Body Mass Index =23
•5.HbA1c 48-85mmol/mol (last known result within in the previous 6 months)
•6.BP <145/90mmHg
•7.Echocardiographic LV hypertrophy (defined as either an LV mass index of >115g/m2 for men and >95g/m2 for women indexed to body surface area or > 44g/m2.7 or 48g/m2.7 when indexed to height) within the previous 6 months.
•8.Women of childbearing potential must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•1.Any condition that in the opinion of the investigator may render the participant unable to complete the trial including non CV disease (e.g. active malignancy).
•2.Participants with type 1 diabetes mellitus
•3.Diagnosis of clinical heart failure
•4.History of humun immunodeficiency virus
•5.LV systolic dysfunction (LVEF <45%) (last known result within in the previous 6 months)
•6.eGFR <45ml/min (last known result within in the previous month)
•7.Known liver function tests >3 times upper limit of normal (based on last measures and documented laboratory measurement in the previous 6 months)
•8.Body weight >150Kg (unable to fit into a MRI scanner)
•9.Contraindications to MRI (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
•10.Past or current treatment with any SGLT2 inhibitor
•11.Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
•12.Current treatment with loop diuretic
•13.Currently receiving long term (>30 consecutive days) treatment with an oral steroid
•14.Pregnant or breast feeding participants
•15.Involvement in the planning and/or conduct of the trial (applies to Astra Zeneca or representative staff and/or staff at the trial site).
•16.Participation in another interventional study (other than observational trials and registries) within 30 days before visit 1.
•17.Individuals considered at risk for poor protocol or medication compliance.

发起方

niversity of Dundee & NHS Tayside