EUCTR2022-002650-48-IE进行中（未招募）1 期
The impact of Empagliflozin on Left atrIal Volume and the feasibility of using Fitbit and mHealth to prescribe Exercise in non-diabetic Pre- Heart Failure (ELIVE pre-HF Study)
niversity College Dublin0 个研究点目标入组 100 人开始时间: 2023年1月17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
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1)Aged >40 years old with at least one cardiovascular risk factor(s) including:
- •a.Hypertension
- •b.Coronary artery disease
- •d.Previous ischaemic stroke or TIA
- •e.Peripheral vascular disease
- •f.Hypercholesterolaemia
- •g.Previous chemotherapy or radiotherapy to the chest
- •2)Not currently on SGLT-2i treatment
- •3)LAVI =29mL/m2 obtained by Doppler echocardiography
- •4)Are able and agree to Fitbit use and exercise prescription
- •5)Subjects must be able and willing to give written informed consent
- •6)Access to a smart phone
- •7)Non-diabetic
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Aged >85years old
- •2.Subjects with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
- •3.Recent (within 3 months) acute myocardial infarction or stroke
- •4.Permanent or persistent Atrial Fibrillation
- •5.Any diabetes mellitus
- •6.Contraindication to SGLT-2i
- •7.Renal insufficiency with eGFR <20mL per min per 1.73m2. For those patients randomised to the substudy CMR with gadolinium, the eGFR cut off will be <30mL per min per 1.73m2.
- •8.A history of HF
- •9.Asymptomatic left ventricular systolic dysfunction as defined as LVEF <50% on most recent measurement.
- •10.Presence of haemodynamically significant mitral and /or aortic valve disease
- •11.Conditions that are expected to compromise survival over the study period
- •12.Concomitant participation in other interventional clinical trials
- •13.Subjects with contraindications to MRI or allergic reactions to MRI contrast dye (Dotarem)
- •14.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drugs.
- •15.Women who are pregnant, breast-feeding, or women of childbearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estro-progestative oral or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. (Contraception must be continued for one week following discontinuation of study drug).
- •16.Refusal to provide informed consent
- •17.Unable to exercise due to concomitant medical condition, such as severe arthritis, uncontrolled pain, severe airways disease or falls risk.
- •18.Cognitive impairment
- •19.Systolic blood pressure <100mmHg
研究者
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