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Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)

2017年11月10日 更新者：Duke University

Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.

研究概览

地位

终止

条件

干预/治疗

详细说明

Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

研究类型

介入性

注册 (实际的)

894

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4Z6
        • Foothills Medical Centre
      • Edmonton、Alberta、加拿大、T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Vancouver General Hospital
      • Vancouver、British Columbia、加拿大、V6Z 1Y6
        • Saint Paul's Hospital
    • Ontario
      • Hamilton、Ontario、加拿大、L8L 2X2
        • Hamilton Health Sciences
      • Toronto、Ontario、加拿大、M5B 1W8
        • St. Michaels Hospital
  • 美国
    • Alabama
      • Huntsville、Alabama、美国、35801
        • The Heart Center PC
    • California
      • Sacramento、California、美国、95819
        • Sutter Memorial Hospital
      • San Diego、California、美国、92037
        • University of California San Diego Medical Center
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University School of Medicine
    • Florida
      • Coral Springs、Florida、美国、33065
        • Holy Cross Medical Group
      • Fort Lauderdale、Florida、美国、33308
        • Holy Cross Hospital
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University
      • Augusta、Georgia、美国、30901
        • University Cardiology Associates, LLC
    • Illinois
      • Aurora、Illinois、美国、60504
        • Fox Valley Clinical Research Center, LLC
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Krannert Institute of Cardiology
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland
      • Beltsville、Maryland、美国、20705
        • Metropolitan Cardiovascular Consultants
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02215
        • Beth Israel Medical Center
      • Haverhill、Massachusetts、美国、01830
        • Pentucket Medical Associates
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Missouri
      • San Luis、Missouri、美国、63112
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Cherry Hill、New Jersey、美国、08034
        • Cardiovascular Associates of the Delaware Valley
      • New Brunswick、New Jersey、美国、08903
        • Robert Wood Johnson University Hospital
      • Sewell、New Jersey、美国、08080
        • Cardiovascular Associates of the Delaware Valley
    • New York
      • Bronx、New York、美国、10461
        • Jacobi Medical Center
      • Bronx、New York、美国、10457
        • Bronx-Lebanon Hospital Center
      • Bronx、New York、美国、10467
        • Albert Einstein University Hospital
      • Brooklyn、New York、美国、11215
        • New York Methodist Hospital
      • Saratoga Springs、New York、美国、12866
        • Saratoga Cardiology Associates
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina at Chapel Hill
      • Charlotte、North Carolina、美国、28204
        • Novant Health Heart and Vascular Institute
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
      • Greensboro、North Carolina、美国、27401
        • LeBauer Cardiovascular Research Foundation
    • Ohio
      • Cincinnati、Ohio、美国、45267
        • University of Cincinnati Medical Center
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Camp Hill、Pennsylvania、美国、17011
        • Capitol Area Research, LLC
      • Philadelphia、Pennsylvania、美国、19102
        • Drexel University College of Medicine
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University Hospital
      • Pittsburg、Pennsylvania、美国、15212
        • Allegheny-Singer Research Institute
    • South Carolina
      • Anderson、South Carolina、美国、29621
        • AnMed Health Medical Center
    • Texas
      • Dallas、Texas、美国、75390
        • University of Texas Southwestern Medical Center Dallas
    • Utah
      • Murray、Utah、美国、84157
        • Intermountain Medical Center
    • Virginia
      • Chesapeake、Virginia、美国、23320
        • Cardiovascular Associates, Ltd.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 years or older
  • Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
  • High risk heart failure as defined by the following criteria:

A Heart Failure Event in the prior 12 months, defined as any one of the following:

  • HF Hospitalization
  • Treatment in the Emergency Department (or equivalent) for Heart Failure
  • Outpatient treatment for heart failure with intravenous diuretics

AND

  • NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization
  • Willing to provide informed consent

Exclusion Criteria:

  • Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
  • Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device
  • Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
  • Severe stenotic valvular disease
  • Anticipated heart transplantation or ventricular assist device within 12 months
  • Chronic inotropic therapy
  • Complex congenital heart disease
  • End stage renal disease with renal replacement therapy
  • Non cardiac terminal illness with expected survival less than 12 months
  • Women who are pregnant or planning to become pregnant
  • Inability to comply with planned study procedures
  • Enrollment or planned enrollment in another clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Usual Care
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
其他：日常护理
日常护理
实验性的：Biomarker-Guided Care
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
设备：Biomarker-guided care NT-proBNP
Device: NT-proBNP

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
CV Death or Heart Failure Hospitalization
大体时间：24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
24 Months

次要结果测量

结果测量
措施说明
大体时间
All-cause Mortality
大体时间：24 months
All-cause mortality by treatment arm
24 months
Cumulative Morbidity
大体时间：24 months
Days alive and not hospitalized for CV reasons
24 months
CV Death
大体时间：24 months
CV death by treatment arm
24 months
Number of Hospitalizations for First Heart Failure
大体时间：24 months
First Heart Failure Hospitalization
24 months
Number of Hospitalizations for Recurrent Heart Failure
大体时间：24 months
Recurrent Heart Failure Hospitalization
24 months
Percentage of Patients With Moderate to Severe Depression
大体时间：Baseline, 3,6, 12 and 24 months

Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D).

CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.
Baseline, 3,6, 12 and 24 months
Duke Activity Status Index (DASI)
大体时间：Baseline, 3, 6, 12 and 24 months
The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Baseline, 3, 6, 12 and 24 months
EQ-5D Health Index
大体时间：Baseline, 3, 6, 12 and 24 months
The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
Baseline, 3, 6, 12 and 24 months
EQ-5D Visual Analog Scale
大体时间：Baseline, 3, 6, 12 and 24 months
The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
Baseline, 3, 6, 12 and 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
大体时间：Baseline, 3, 6,12 and 24 months
This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Baseline, 3, 6,12 and 24 months
Short Form-36 (SF-36) General Health Subscale
大体时间：Baseline, 3, 6, 12 and 24 months
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Mental Health Subscale
大体时间：Baseline, 3, 6, 12 and 24 months
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Social Functioning Subscale
大体时间：Baseline, 3, 6, 12 and 24 months
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Physiological Functioning Subscale
大体时间：Baseline, 3, 6, 12 and 24 months
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Vitality Subscale
大体时间：Baseline, 3, 6, 12 and 24 months
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Baseline, 3, 6, 12 and 24 months
Resource Utilization
大体时间：24 months
Observed Resource Use
24 months
Resource Utilization Cost
大体时间：24 months
Observed Hospital-Based Cost.
24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Duke University

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

  • 首席研究员：Michael Felker, MD、Duke University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年12月1日

初级完成 (实际的)

2016年9月20日

研究完成 (实际的)

2016年9月20日

研究注册日期

首次提交

2012年9月12日

首先提交符合 QC 标准的

2012年9月12日

首次发布 (估计)

2012年9月14日

研究记录更新

最后更新发布 (实际的)

2017年12月12日

上次提交的符合 QC 标准的更新

2017年11月10日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Pro00033097

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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