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临床试验/NCT01619891
NCT01619891已完成2 期

VitamIN D Treating patIents With Chronic heArT failurE

University of Leeds2 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
253
试验地点
2
主要终点
6 minute walk distance

研究概览

简要总结

Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.

详细描述

This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.

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

入选标准

  • Class II or III CHF
  • Stable symptoms (on otherwise optimally tolerated medical therapy)
  • Able to give written informed consent

排除标准

  • Currently taking vitamin D supplementation
  • Untreated valvular heart disease
  • Existing class I indication for vitamin D therapy
  • History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia
  • Heart failure due to anaemia or thyrotoxicosis
  • Renal failure (GFR <30l/min)

结局指标

主要结局

6 minute walk distance

时间窗: After one year

次要结局

  • Left ventricular function by Cardiac Magnetic Resonance(At one year)
  • Peak exercise capacity(At one year)
  • Biochemical changes(At one year (but also throughout))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

KK Witte

Senior Lecturer in Cardiology

University of Leeds

研究点 (2)

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