Vitamin D Supplementation for Treatment of Heart Failure (DELIGHTFUL)
D suppLementation In HearT FaiLure (DELIGHTFUL)
調査の概要
詳細な説明
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.
Working Hypothesis 4: HF patients with CYP2R1 variant alleles will have shorter 6-minute walk length compared to subjects without these variants.
To genotype HF subjects for the VDR variants and additional tag SNPs, to ascertain the relationship between VDR genetic variation and surrogate markers in systolic HF patients.
Working Hypothesis 5: HF patients with VDR variants will have greater measures of inflammation and extracellular-matrix remodeling compared to subjects without VDR variants.
Working Hypothesis 6: HF patients with VDR variants will have a shorter 6-minute walk length compared to subjects without these variants.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ: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
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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
他の名前:
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プラセボコンパレーター:Placebo
A placebo loading dose will be given followed by two placebo tablets daily for 6 months.
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A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Biomarkers
時間枠:6 months
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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).
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Exercise Capacity Measured by 6 Minute Walk Test
時間枠:6 months
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6 months
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Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire
時間枠:6 months
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Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.
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6 months
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Vitamin D Genomics
時間枠:Baseline
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Genotyped for the restricted fragment length polymorphism at the BsmI site.
In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.
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Baseline
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Barry E. Bleske, Pharm. D.、University of Michigan
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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