CTIS2024-512062-34-00招募中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: 2024年2月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Aged >40 years old with at least one cardiovascular risk factor(s) including: a. Hypertension b. Coronary artery disease c. Obesity d. Previous ischaemic stroke or TIA e. Peripheral vascular disease f. Hypercholesterolaemia g. Previous chemotherapy or radiotherapy to the chest, Not currently on SGLT-2i treatment, LAVI =29mL/m2 obtained by Doppler echocardiography, Are able and agree to Fitbit use and exercise prescription, Subjects must be able and willing to give written informed consent, Access to a smart phone, Non-diabetic
排除标准
- •Aged >85years old, Presence of haemodynamically significant mitral and /or aortic valve disease, Conditions that are expected to compromise survival over the study period, Concomitant participation in other interventional clinical trials, Subjects with contraindications to MRI or allergic reactions to MRI contrast dye (Dotarem), Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drugs., 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), Refusal to provide informed consent, Unable to exercise due to concomitant medical condition, such as severe arthritis, uncontrolled pain, severe airways disease or falls risk., Cognitive impairment, Systolic blood pressure <100mmHg, Subjects with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, Recent (within 3 months) acute myocardial infarction or stroke, Permanent or persistent Atrial Fibrillation, Any diabetes mellitus, Contraindication to SGLT-2i, 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 ., A history of HF, Asymptomatic left ventricular systolic dysfunction as defined as LVEF <50% on most recent measurement.
研究者
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