Interleukin-1 Blockade in Recently Decompensated Heart Failure (RED-HART)
Interleukin-1 Blockade in Recently Decompensated Heart Failure: A Randomized Placebo-controlled Double-blinded Study
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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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:
All 6 criteria need to be met for enrollment of the patient in the study
Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:
- dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;
evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);
- pulmonary congestion/edema at physical exam OR chest X-Ray;
- plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml;
- invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
- The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
- absence of dyspnea or pulmonary congestion/distress at rest;
- absence of pitting edema in the lower extremities, or in any other region;
- stable hemodynamic parameters (blood pressure, heart rate).
- The patient is of age ≥21 years old, and is willing and able to provide written informed consent.
- The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
- The patient has screening plasma C-reactive protein levels >2 mg/L.
Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria.
- The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
- Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration.
- Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
- Previous or planned implantation of left ventricular assist devices or heart-transplant.
- Chronic use of intravenous inotropes.
- Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
- Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
- Active infection (of any type);
- Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).
- Prior (within the past 10 years) or current malignancy.
- Any comorbidity limiting survival or ability to complete the study.
- End stage kidney disease requiring renal replacement therapy.
- Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
- Pregnancy.
- Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Anakinra (short)
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
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Anakinra 100 mg daily for weeks 1 and 2
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実験的:Anakinra (long)
Anakinra 100 mg daily for 12 weeks
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Anakinra 100 mg daily for weeks 1 and 2
他の名前:
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プラセボコンパレーター:Placebo
Placebo injections daily for 12 weeks
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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 |
---|---|---|
Interval Changes in Peak Oxygen Consumption (VO2)
時間枠:Baseline to 2 weeks
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Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.
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Baseline to 2 weeks
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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 |
---|---|---|
Quality of Life Improvement
時間枠:12 weeks
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The Duke Activity Status Index questionnaire will be completed at enrollment and 12 weeks.
The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks).
Higher scores represent increased ability to perform daily activities and may be interpreted as improved quality of life.
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12 weeks
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Death or Hospital Admission for Heart Failure
時間枠:24 weeks
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We will monitor survival and hospitalization for heart failure throughout the 24 week follow-up
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24 weeks
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協力者と研究者
捜査官
- 主任研究者:Benjamin W Van Tassell, PharmD、Virginia Commonwealth University
出版物と役立つリンク
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RED-HART (HM15339)
- 1R34HL117026 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
心不全の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
プラセボの臨床試験
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Palacky University完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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University Hospital, Strasbourg, France積極的、募集していない