D suppLementation In HearT FaiLure (DELIGHTFUL)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Biomarkers
研究概览
简要总结
The central objective of this proposal is to establish that vitamin D supplementation in heart failure patients with low vitamin D levels will have improved outcomes compared to placebo. In addition the investigators will also evaluate the role of genetics in regard to vitamin D and heart failure. The investigators will be evaluating what is currently a novel approach of identifying patients with low vitamin D and treating this low vitamin D level. The investigators will be able to evaluate the importance of vitamin D supplementation in these patients and the role of genetics on our defined outcomes.
详细描述
Primary Objective To determine how rapid vitamin D supplementation affects biomarkers and submaximal exercise capacity in systolic HF patients with low vitamin D status.
Working Hypothesis 1: HF patients when supplemented with vitamin D for 6 months will have lower measures of inflammation and extracellular-matrix remodeling compared with placebo.
Working Hypothesis 2: HF patients when supplemented with vitamin D for 6 months will have longer 6-minute walk length compared with placebo.
Secondary Objectives To establish a relationship between the CYP2R1 variant and surrogate markers in systolic HF patients.
Working Hypothesis 3: HF patients with the CYP2R1 G allele will have higher measures of inflammation and extracellular-matrix remodeling compared to AA subjects. This relationship will also be seen in subjects with the CYP2R1 TagSNP variants.
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
- Double (Participant, Care Provider)
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
- •HF patients with LV systolic dysfunction of ischemic or non-ischemic origin and an LVEF <40% using nuclear ventriculography or echocardiography within the last 6 months.
- •Attempts should have been made at optimizing medical therapy and the participant should be stable on these medications for at least 3 months.
- •Patients with a 25(OH)D level between 10-25 ng/ml
排除标准
- •Inability to give informed consent
- •Patients with sarcoidosis or other granulomatous disease that can alter vitamin D metabolism
- •Patients with primary valvular HF, hypertrophic cardiomyopathy, and drug-induced HF
- •Renal dysfunction defined as serum creatinine > 2.5 mg/dl
- •Pregnant women
- •Patients <18 years of age
- •Patients on vitamin D supplementation
研究组 & 干预措施
Vitamin D
Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
干预措施: Vitamin D3 (Drug)
Placebo
A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Biomarkers
时间窗: 6 months
Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).
次要结局
- Exercise Capacity Measured by 6 Minute Walk Test(6 months)
- Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire(6 months)
- Vitamin D Genomics(Baseline)
研究者
Barry E. Bleske
Associate Professor
University of Michigan