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Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT) (FIGHT)

2017年2月14日 更新者：Duke University

Functional Impact of GLP-1 for Heart Failure Treatment

The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerable post-discharge period to enhance clinical stability and prevent early HF mortality and readmissions.

As heart failure (HF) progresses, impairments in metabolism render the heart substrate constrained, limiting cardiac metabolism. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin peptide that enhances cellular glucose uptake by stimulating insulin secretion and insulin sensitivity in target tissues. Preclinical and early-phase clinical data support GLP-1 as an effective therapy for advanced HF while use of GLP-1 receptor agonists in large numbers of patients with diabetes reveal a good safety profile and reductions in adverse cardiac outcomes.

研究の種類

介入

入学 (実際)

300

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Delaware
      • Newark、Delaware、アメリカ、19718
        • Christiana Care Health Services
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • Emory University School of Medicine
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Northwestern University
    • Maryland
      • Baltimore、Maryland、アメリカ、21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、アメリカ、02111
        • Tufts Medical Center
      • West Roxbury、Massachusetts、アメリカ、02132
        • Boston VA Healtcare System
    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
        • Mayo Clinic
    • Missouri
      • St. Louis、Missouri、アメリカ、63110
        • Washington University
      • St. Louis、Missouri、アメリカ、63117
        • Saint Louis University Hospital
    • North Carolina
      • Durham、North Carolina、アメリカ、27705
        • Duke University
      • Lumberton、North Carolina、アメリカ、28538
        • Southeast Regional Medical Center
    • Ohio
      • Cleveland、Ohio、アメリカ、44195
        • Cleveland Clinic
      • Cleveland、Ohio、アメリカ、44109
        • Metro Health System
      • Cleveland、Ohio、アメリカ、44106
        • University Hospitals- Case Medical Center
    • Pennsylvania
      • Lancaster、Pennsylvania、アメリカ、17603
        • Lancaster Heart and Stroke Foundation
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Jefferson Medical College
      • Philadelphia、Pennsylvania、アメリカ、19140
        • Temple University Hospital
      • Philadelphia、Pennsylvania、アメリカ、19104
        • University of Pennsylvaina
    • Texas
      • Houston、Texas、アメリカ、77030
        • Michael DeBakey VA Medical Center
    • Utah
      • Murray、Utah、アメリカ、84157
        • Intermountain Medical Center
      • Salt Lake City、Utah、アメリカ、84132
        • University of Utah School of Medicine
      • Salt Lake City、Utah、アメリカ、84132
        • Utah VA Medical Center
    • Vermont
      • Burlington、Vermont、アメリカ、05401
        • The University of Vermont- Fletcher Allen Health Care

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age ≥ 18 years
  2. AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
  3. AHFS is the primary cause of hospitalization
  4. Prior clinical diagnosis of HF
  5. Left Ventricular Ejection Fraction(LVEF) ≤ 40% during the preceding 3 months (if no echo within the preceding 3 months, an LVEF ≤ 30% during the preceding three years is acceptable)
  6. On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant
  7. Use of at least 80 mg or furosemide total daily dose (or equivalent) prior to admission for AHFS (a lower dose of a loop diuretic combined with a thiazide will count as an "equivalent")
  8. Willingness to provide informed consent

Exclusion Criteria:

  1. AHFS due to acute myocarditis or acute Myocardial Infarction
  2. Ongoing hemodynamically significant arrhythmias contributing to HF decompensation
  3. Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient.
  4. Current or planned left ventricular assist device therapy in next 180 days
  5. United Network for Organ Sharing status 1A or 1B
  6. B-type natriuretic peptide(BNP)< 250 or NT-proBNP<1,000 (Not required per protocol but if available and too low would be an exclusion; within 48 hours of consent)
  7. Hemoglobin (Hgb) < 8.0 g/dl
  8. Glomerular filtration rate(GFR) < 20 ml/min/1.73 m2 within 48 hours of consent
  9. Systolic blood pressure < 80 mmHg at consent
  10. Resting Heart Rate > 110 at consent
  11. Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
  12. Percutaneous Coronary Intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks
  13. Primary hypertrophic cardiomyopathy
  14. Infiltrative cardiomyopathy
  15. Constrictive pericarditis or tamponade
  16. Complex congenital heart disease
  17. Non-cardiac pulmonary edema
  18. More than moderate aortic or mitral stenosis
  19. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
  20. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
  21. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, International Normalized Ration (INR) > 1.7 in the absence of anticoagulation treatment
  22. Terminal illness (other than HF) with expected survival of less than 1 year
  23. Previous adverse reaction to the study drug
  24. Receipt of any investigational product in the previous 30 days.
  25. Enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.
  26. Inability to comply with planned study procedures
  27. Pregnancy or breastfeeding mothers
  28. Women of reproductive age not on adequate contraception
  29. History of acute or chronic pancreatitis
  30. History of symptomatic gastroparesis
  31. Familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (MEN2)
  32. Prior weight-loss surgery (i.e., Roux-en-Y gastric bypass) or other gastric surgery associated with increased endogenous GLP-1 production
  33. Prior or ongoing treatment with GLP-1 receptor agonists
  34. Ongoing treatment with dipeptidyl peptide-IV inhibitors (1 week washout required)
  35. Ongoing treatment with thiazolidinedione
  36. Oxygen-dependent chronic obstructive pulmonary disease
  37. Diabetic patients with history of 2 or more severe hypoglycemia, Diabetic Ketoacidosis(DKA) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.
  38. Diagnosis of Type 1 Diabetes Mellitus

40. If diabetic, inadequate glycemic control with glucose level > 300 mg/dL within 24 hours of randomization

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
アクティブコンパレータ：Liraglutide
Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily.
薬：Liraglutide
Active Drug
他の名前：
  • ビクトザ
プラセボコンパレーター：Placebo
Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily.
薬：プラセボ
プラセボ

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
Global Ranking of Predefined Events
時間枠：Randomization to 180 days
A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.
Randomization to 180 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Left Ventricular End-Diastolic Volume Index
時間枠：Baseline to 180 days
Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.
Baseline to 180 days
Change in Left Ventricular End-systolic Volume Index
時間枠：Baseline to 180 days
Change in left ventricular end-systolic volume index from baseline to day 180.
Baseline to 180 days
Change in Left Ventricular Ejection Fraction
時間枠：Baseline to 180 days
Change in left ventricular ejection fraction from baseline to day 180
Baseline to 180 days
Change in Medial Filling Pressure
時間枠：Baseline to 180 days
Change in medial filling pressure baseline to day 180.
Baseline to 180 days
Change in Lateral Filling Pressure
時間枠：Baseline to 180 days
Change in lateral filling pressure baseline to day 180.
Baseline to 180 days
Change in 6 Minute Walk Distance
時間枠：Baseline to day 30
Change in 6 minute walk distance baseline to day 30
Baseline to day 30
Change in 6 Minute Walk Distance
時間枠：Baseline to 90 days
Change in 6 minute walk distance baseline to 90 days.
Baseline to 90 days
Change in 6 Minute Walk Distance
時間枠：Baseline to 180 days
Change in 6 minute walk distance baseline to 180 days.
Baseline to 180 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
時間枠：Baseline to 30 days
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 30 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
時間枠：Baseline to 90 days
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 90 days
Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
時間枠：Baseline to day 180
Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to day 180
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
時間枠：Baseline to 30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 30 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
時間枠：Baseline to 90 days
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 90 days
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.
時間枠：Baseline to 180 days
Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to 180 days
Individual Component of the Primary Endpoint- Mortality
時間枠：Randomization to 180 days
Individual component of the primary endpoint of mortality at 180 days after randomization
Randomization to 180 days
Individual Component of the Primary Endpoint- Heart Failure Hospitalization
時間枠：Randomization to 180 days
Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days
Randomization to 180 days
Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP
時間枠：Baseline to 180 days
Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days
Baseline to 180 days
Global Ranking of Predefined Events
時間枠：Baseline to 180 days
A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.
Baseline to 180 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Duke University

協力者

National Heart, Lung, and Blood Institute (NHLBI)

捜査官

  • スタディチェア：Eugene Bruanwald, MD、Harvard University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年4月1日

一次修了 (実際)

2015年10月1日

研究の完了 (実際)

2015年10月1日

試験登録日

最初に提出

2013年2月7日

QC基準を満たした最初の提出物

2013年2月26日

最初の投稿 (見積もり)

2013年2月28日

学習記録の更新

投稿された最後の更新 (実際)

2017年2月15日

QC基準を満たした最後の更新が送信されました

2017年2月14日

最終確認日

2017年2月1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

  • Pro00042633
  • 5U10HL084904-09 (米国 NIH グラント/契約)

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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