Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)
10 de novembro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
894
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 4Z6
- Foothills Medical Centre
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Edmonton, Alberta, Canadá, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, Canadá, V6Z 1Y6
- Saint Paul's Hospital
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Ontario
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Hamilton, Ontario, Canadá, L8L 2X2
- Hamilton Health Sciences
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Toronto, Ontario, Canadá, M5B 1W8
- St. Michaels Hospital
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Alabama
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Huntsville, Alabama, Estados Unidos, 35801
- The Heart Center PC
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California
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Sacramento, California, Estados Unidos, 95819
- Sutter Memorial Hospital
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San Diego, California, Estados Unidos, 92037
- University of California San Diego Medical Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale University School of Medicine
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Florida
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Coral Springs, Florida, Estados Unidos, 33065
- Holy Cross Medical Group
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Fort Lauderdale, Florida, Estados Unidos, 33308
- Holy Cross Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Augusta, Georgia, Estados Unidos, 30901
- University Cardiology Associates, LLC
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Illinois
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Aurora, Illinois, Estados Unidos, 60504
- Fox Valley Clinical Research Center, LLC
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Krannert Institute of Cardiology
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland
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Beltsville, Maryland, Estados Unidos, 20705
- Metropolitan Cardiovascular Consultants
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Medical Center
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Haverhill, Massachusetts, Estados Unidos, 01830
- Pentucket Medical Associates
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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San Luis, Missouri, Estados Unidos, 63112
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Cherry Hill, New Jersey, Estados Unidos, 08034
- Cardiovascular Associates of the Delaware Valley
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New Brunswick, New Jersey, Estados Unidos, 08903
- Robert Wood Johnson University Hospital
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Sewell, New Jersey, Estados Unidos, 08080
- Cardiovascular Associates of the Delaware Valley
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New York
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Bronx, New York, Estados Unidos, 10461
- Jacobi Medical Center
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Bronx, New York, Estados Unidos, 10457
- Bronx-Lebanon Hospital Center
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Bronx, New York, Estados Unidos, 10467
- Albert Einstein University Hospital
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Brooklyn, New York, Estados Unidos, 11215
- New York Methodist Hospital
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Saratoga Springs, New York, Estados Unidos, 12866
- Saratoga Cardiology Associates
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Estados Unidos, 28204
- Novant Health Heart and Vascular Institute
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Greensboro, North Carolina, Estados Unidos, 27401
- LeBauer Cardiovascular Research Foundation
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267
- University of Cincinnati Medical Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Camp Hill, Pennsylvania, Estados Unidos, 17011
- Capitol Area Research, LLC
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Philadelphia, Pennsylvania, Estados Unidos, 19102
- Drexel University College of Medicine
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University Hospital
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Pittsburg, Pennsylvania, Estados Unidos, 15212
- Allegheny-Singer Research Institute
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South Carolina
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Anderson, South Carolina, Estados Unidos, 29621
- AnMed Health Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center Dallas
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Utah
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Murray, Utah, Estados Unidos, 84157
- Intermountain Medical Center
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Virginia
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Chesapeake, Virginia, Estados Unidos, 23320
- Cardiovascular Associates, Ltd.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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Cuidados usuais
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Experimental: 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.
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Device: NT-proBNP
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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CV Death or Heart Failure Hospitalization
Prazo: 24 Months
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Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
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24 Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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All-cause Mortality
Prazo: 24 months
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All-cause mortality by treatment arm
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24 months
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Cumulative Morbidity
Prazo: 24 months
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Days alive and not hospitalized for CV reasons
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24 months
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CV Death
Prazo: 24 months
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CV death by treatment arm
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24 months
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Number of Hospitalizations for First Heart Failure
Prazo: 24 months
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First Heart Failure Hospitalization
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24 months
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Number of Hospitalizations for Recurrent Heart Failure
Prazo: 24 months
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Recurrent Heart Failure Hospitalization
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24 months
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Percentage of Patients With Moderate to Severe Depression
Prazo: Baseline, 3,6, 12 and 24 months
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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
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Duke Activity Status Index (DASI)
Prazo: Baseline, 3, 6, 12 and 24 months
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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).
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Baseline, 3, 6, 12 and 24 months
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EQ-5D Health Index
Prazo: Baseline, 3, 6, 12 and 24 months
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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).
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Baseline, 3, 6, 12 and 24 months
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EQ-5D Visual Analog Scale
Prazo: Baseline, 3, 6, 12 and 24 months
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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.
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Baseline, 3, 6, 12 and 24 months
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Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
Prazo: Baseline, 3, 6,12 and 24 months
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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.
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Baseline, 3, 6,12 and 24 months
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Short Form-36 (SF-36) General Health Subscale
Prazo: Baseline, 3, 6, 12 and 24 months
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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.
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Baseline, 3, 6, 12 and 24 months
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Short Form-36 (SF-36) Mental Health Subscale
Prazo: Baseline, 3, 6, 12 and 24 months
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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.
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Baseline, 3, 6, 12 and 24 months
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Short Form-36 (SF-36) Social Functioning Subscale
Prazo: Baseline, 3, 6, 12 and 24 months
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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.
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Baseline, 3, 6, 12 and 24 months
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Short Form-36 (SF-36) Physiological Functioning Subscale
Prazo: Baseline, 3, 6, 12 and 24 months
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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.
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Baseline, 3, 6, 12 and 24 months
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Short Form-36 (SF-36) Vitality Subscale
Prazo: Baseline, 3, 6, 12 and 24 months
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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.
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Baseline, 3, 6, 12 and 24 months
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Resource Utilization
Prazo: 24 months
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Observed Resource Use
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24 months
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Resource Utilization Cost
Prazo: 24 months
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Observed Hospital-Based Cost.
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24 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Felker, MD, Duke University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Ezekowitz JA, Alemayehu W, Rathwell S, Grant AD, Fiuzat M, Whellan DJ, Ahmad T, Adams K, Pina IL, Cooper LS, Januzzi JL, Leifer ES, Mark D, O'Connor CM, Felker GM. The influence of comorbidities on achieving an N-terminal pro-b-type natriuretic peptide target: a secondary analysis of the GUIDE-IT trial. ESC Heart Fail. 2022 Feb;9(1):77-86. doi: 10.1002/ehf2.13692. Epub 2021 Nov 16.
- Chouairi F, Fuery MA, Mullan CW, Caraballo C, Sen S, Maulion C, Wilkinson ST, Surti T, McCullough M, Miller PE, Pacor J, Leifer ES, Felker GM, Velazquez EJ, Fiuzat M, O'Connor CM, Januzzi JL, Desai NR, Ahmad T. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial. J Card Fail. 2021 Dec;27(12):1359-1366. doi: 10.1016/j.cardfail.2021.06.008. Epub 2021 Jun 22.
- Fuery MA, Chouairi F, Januzzi JL, Moe GW, Caraballo C, McCullough M, Miller PE, Reinhardt SW, Clark K, Oseran A, Milner A, Pacor J, Kahn PA, Singh A, Ravindra N, Guha A, Vadlamani L, Kulkarni NS, Fiuzat M, Felker GM, O'Connor CM, Ahmad T, Ezekowitz J, Desai NR. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure. JACC Heart Fail. 2021 Jul;9(7):497-505. doi: 10.1016/j.jchf.2021.02.011. Epub 2021 May 12.
- Daubert MA, Yow E, Barnhart HX, Pina IL, Ahmad T, Leifer E, Cooper L, Desvigne-Nickens P, Fiuzat M, Adams K, Ezekowitz J, Whellan DJ, Januzzi JL, O'Connor CM, Felker GM. Differences in NT-proBNP Response and Prognosis in Men and Women With Heart Failure With Reduced Ejection Fraction. J Am Heart Assoc. 2021 May 18;10(10):e019712. doi: 10.1161/JAHA.120.019712. Epub 2021 May 6.
- Parcha V, Patel N, Kalra R, Suri SS, Arora G, Wang TJ, Arora P. Obesity and Serial NT-proBNP Levels in Guided Medical Therapy for Heart Failure With Reduced Ejection Fraction: Insights From the GUIDE-IT Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e018689. doi: 10.1161/JAHA.120.018689. Epub 2021 Mar 23.
- Fiuzat M, Ezekowitz J, Alemayehu W, Westerhout CM, Sbolli M, Cani D, Whellan DJ, Ahmad T, Adams K, Pina IL, Patel CB, Anstrom KJ, Cooper LS, Mark D, Leifer ES, Felker GM, Januzzi JL, O'Connor CM. Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):757-764. doi: 10.1001/jamacardio.2020.0640.
- Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
- O'Connor C, Fiuzat M, Mulder H, Coles A, Ahmad T, Ezekowitz JA, Adams KF, Pina IL, Anstrom KJ, Cooper LS, Mark DB, Whellan DJ, Januzzi JL Jr, Leifer ES, Felker GM. Clinical factors related to morbidity and mortality in high-risk heart failure patients: the GUIDE-IT predictive model and risk score. Eur J Heart Fail. 2019 Jun;21(6):770-778. doi: 10.1002/ejhf.1450. Epub 2019 Mar 27.
- Daubert MA, Adams K, Yow E, Barnhart HX, Douglas PS, Rimmer S, Norris C, Cooper L, Leifer E, Desvigne-Nickens P, Anstrom K, Fiuzat M, Ezekowitz J, Mark DB, O'Connor CM, Januzzi J, Felker GM. NT-proBNP Goal Achievement Is Associated With Significant Reverse Remodeling and Improved Clinical Outcomes in HFrEF. JACC Heart Fail. 2019 Feb;7(2):158-168. doi: 10.1016/j.jchf.2018.10.014. Epub 2019 Jan 2.
- Mark DB, Cowper PA, Anstrom KJ, Sheng S, Daniels MR, Knight JD, Baloch KN, Davidson-Ray L, Fiuzat M, Januzzi JL Jr, Whellan DJ, Pina IL, Ezekowitz JA, Adams KF, Cooper LS, O'Connor CM, Felker GM. Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure. J Am Coll Cardiol. 2018 Nov 27;72(21):2551-2562. doi: 10.1016/j.jacc.2018.08.2184.
- Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
- Felker GM, Ahmad T, Anstrom KJ, Adams KF, Cooper LS, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL, Leifer ES, Mark DB, Desvigne-Nickens P, Paynter G, Pina IL, Whellan DJ, O'Connor CM. Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. JACC Heart Fail. 2014 Oct;2(5):457-65. doi: 10.1016/j.jchf.2014.05.007. Epub 2014 Sep 3.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2012
Conclusão Primária (Real)
20 de setembro de 2016
Conclusão do estudo (Real)
20 de setembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
12 de setembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de setembro de 2012
Primeira postagem (Estimativa)
14 de setembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de dezembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00033097
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .