2024-513448-26-00招募中4 期
Effects of Digoxin in Modern Heart Failure Treatment
Unidade Local De Saude De Sao Jose E.P.E.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月13日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peak oxygen consumption measured by Cardiopulmonary Exercise Test at 24 weeks.
研究概览
简要总结
To assess the effectiveness of Digoxin in functional capacity and cardiac function when combined with standard of care modern heart failure treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Crossover design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure with reduced ejection fraction (LVEF ≤45%) with at least 6 months of maximally tolerated class I medications (ARNi or ACEiplus beta-blockers plus SGLT2 inhibitors plus MRA) unless contraindicated.
- •Symptomatic heart failure with at least New York Heart Association (NYHA) class ≥ II in which Digoxin may be considered according tocurrent European Guidelines.
- •Age ≥ 18 years old.
- •Ability to provide informed consent and willingness to comply with studyprocedures.
排除标准
- •Already using Digoxin or having used it on the last 9 days (washout period).
- •Pregnant or lactating women. Woman of childbearing potential who do not accept to use the methods of contraception suggested for the trial.
- •New heart failure medication in the previous 6 months.
- •Change in class I HF dose (ARNi, ACEi, ARB, beta-blockers, SGLT2 inhibitors or MRA) in the previous 3 months.
- •Recent (<6 months): myocardial infarction, coronary revascularization, surgery or catheter intervention for valvular heart disease, stroke, or cerebral ischaemia, start of heart failure device therapy potentially improving left ventricular ejection fraction or HF symptoms (e.g. cardiac resynchronization therapy, cardiac contractility modulation, baroreflex activation therapy)
- •Significant renal insufficiency (Glomerular filtration rate (GFR) ≤ 15mL/min) as evaluated by the Cockcroft-Gault formula.
- •NTproBNP values < 125pg/mL.
- •Ventricular tachycardia or ventricular fibrillation
- •Arrhythmias caused by cardiac glycoside intoxication
- •Persistent potassium below 3.2 mmol/L.
- •Persistent hypercalcaemia or hypomagnesaemia.
- •Sick sinus syndrome without pacemaker or Implantable cardioverter-defibrillators (ICD).
- •Grade II-III AV block without a pacemaker or ICD.
- •Wolff-Parkinson-White syndrome.
- •Heart rate below 55 bpm at rest in sinus rhythm or below 70 bpm in AF in patients without CRT or cardiac physiologic pacing.
- •Age < 18 years old.
- •Hypersensitivity to Digoxin, other digitalis glycosides or to any of the excipients
结局指标
主要结局
Peak oxygen consumption measured by Cardiopulmonary Exercise Test at 24 weeks.
Peak oxygen consumption measured by Cardiopulmonary Exercise Test at 24 weeks.
Global Work Index measured by Echocardiography at 24 weeks.
Global Work Index measured by Echocardiography at 24 weeks.
次要结局
- Composite of death, hospitalizations, and ventricular arrhythmia from baseline to 24 weeks.
- KCCQ-12 Score at 24 weeks.
- Changes in analytical parameters at 24 weeks: NTproBNP, Glomerular filtration rate, urine ratio of albumin/creatinine, C-reactive protein, aldosterone and renin plasma values.
- Cardiopulmonary exercise test parameters at 24 weeks: Peak oxygenconsumption (percentage of predicted), Oxygen consumption at anaerobic threshold, VE/VCO2 slope, Duration of exercise, Optimal point of ventilation.
- ECG parameters at 24 weeks: QRS interval.
- Echocardiography parameters at 24 weeks: Global Constructive Work, Global Wasted Work, Global Work Efficiency, Global Longitudinal Strain, Left Ventricular Ejection Fraction, Right ventricular fractional area change, Free-wall right ventricle longitudinal strain, Left ventricle end-diastolic volume, Left Atrial Reservoir Strain, Mechanical dispersion, E/e´
研究者
Coordinator of the Research Centre
Scientific
Unidade Local De Saude De Sao Jose E.P.E.
研究点 (1)
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