Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)
10 de noviembre de 2017 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
894
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Cuidado usual
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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CV Death or Heart Failure Hospitalization
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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All-cause Mortality
Periodo de tiempo: 24 months
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All-cause mortality by treatment arm
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24 months
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Cumulative Morbidity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 months
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Observed Resource Use
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24 months
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Resource Utilization Cost
Periodo de tiempo: 24 months
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Observed Hospital-Based Cost.
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24 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Felker, MD, Duke University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2012
Finalización primaria (Actual)
20 de septiembre de 2016
Finalización del estudio (Actual)
20 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
12 de septiembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2012
Publicado por primera vez (Estimar)
14 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
10 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00033097
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .