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

2017년 11월 10일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

894

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 평상시 관리
평상시 관리
실험적: 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.
장치: Biomarker-guided care NT-proBNP
Device: NT-proBNP

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
CV Death or Heart Failure Hospitalization
기간: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
24 Months

2차 결과 측정

결과 측정
측정값 설명
기간
All-cause Mortality
기간: 24 months
All-cause mortality by treatment arm
24 months
Cumulative Morbidity
기간: 24 months
Days alive and not hospitalized for CV reasons
24 months
CV Death
기간: 24 months
CV death by treatment arm
24 months
Number of Hospitalizations for First Heart Failure
기간: 24 months
First Heart Failure Hospitalization
24 months
Number of Hospitalizations for Recurrent Heart Failure
기간: 24 months
Recurrent Heart Failure Hospitalization
24 months
Percentage of Patients With Moderate to Severe Depression
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 months
Observed Resource Use
24 months
Resource Utilization Cost
기간: 24 months
Observed Hospital-Based Cost.
24 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Duke University

협력자

National Heart, Lung, and Blood Institute (NHLBI)

수사관

  • 수석 연구원: Michael Felker, MD, Duke University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 12월 1일

기본 완료 (실제)

2016년 9월 20일

연구 완료 (실제)

2016년 9월 20일

연구 등록 날짜

최초 제출

2012년 9월 12일

QC 기준을 충족하는 최초 제출

2012년 9월 12일

처음 게시됨 (추정)

2012년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 12월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 11월 10일

마지막으로 확인됨

2017년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00033097

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심부전에 대한 임상 시험

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건강 상태

약물 개입

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CROs in Norway

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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