VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation on Hospitalisation and Mortality in Patients With Heart Failure): Multicentre, Phase III, Randomised Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,253
- 试验地点
- 1
- 主要终点
- Combined heart failure hospitalisation and total mortality
研究概览
简要总结
VINDICATE 2 will be a randomised, placebo-controlled, parallel group, double-blind study of vitamin D versus placebo in otherwise optimally-managed patients with CHF due to LVSD and vitamin D deficiency (<50nmol/L). The intervention will be a daily dose of 4000IU (100µg) per day or matching placebo for a minimum of 2 years and a maximum of 4 years.
详细描述
DESIGN: Multi-centre, phase III, double-blind, parallel-group, placebo-controlled trial.
SETTING: Secondary care heart failure clinics across the UK. TARGET POPULATION: Higher-risk patients with CHF due to LVSD recruited from CHF clinics.
HEALTH TECHNOLOGY: 4000IU (100mcg) vitamin D3 or placebo daily for minimum 2yrs and maximum 4yrs.
MEASUREMENT OF OUTCOMES:
Primary end-point is a composite of HF hospitalisation or death Secondary outcomes include all-cause mortality, hospitalisations and cost-effectiveness. Patient outcomes will be obtained from NHS Digital (KKW is an approved researcher) with a transfer of linked data to be held at the Leeds Institute for Data Analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVSD (LVEF <50%);
- •stable medical and device therapy for >3mths;
- •25[OH]vitamin D3 <50nmol/L
- •At least one of: recent (<1 year) hospitalisation for HF, high dose loop diuretic requirement (>80mg daily furosemide equiv), diabetes mellitus, ischaemic aetiology
排除标准
- •Unwilling/unable to sign consent,
- •Severe cognitive impairment,
- •Severe COPD,
- •Other life-threatening co-morbidity (in the opinion of the local co-investigator),
- •Known and active sarcoidosis or tuberculosis
结局指标
主要结局
Combined heart failure hospitalisation and total mortality
时间窗: 24 months
Time to death or first hospitalisation for heart failure
次要结局
- Total mortality(24 months)
- Change in patient quality of life(24 months)
- Cost effectiveness(24 months)
研究者
KK Witte
Senior Lecturer in Cardiology
University of Leeds