Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)
10. november 2017 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
894
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- Foothills Medical Centre
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Saint Paul's Hospital
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences
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Toronto, Ontario, Canada, M5B 1W8
- St. Michaels Hospital
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Alabama
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Huntsville, Alabama, Forente stater, 35801
- The Heart Center PC
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California
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Sacramento, California, Forente stater, 95819
- Sutter Memorial Hospital
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San Diego, California, Forente stater, 92037
- University of California San Diego Medical Center
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Yale University School Of Medicine
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Florida
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Coral Springs, Florida, Forente stater, 33065
- Holy Cross Medical Group
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Fort Lauderdale, Florida, Forente stater, 33308
- Holy Cross Hospital
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University
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Augusta, Georgia, Forente stater, 30901
- University Cardiology Associates, LLC
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Illinois
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Aurora, Illinois, Forente stater, 60504
- Fox Valley Clinical Research Center, LLC
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Krannert Institute of Cardiology
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland
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Beltsville, Maryland, Forente stater, 20705
- Metropolitan Cardiovascular Consultants
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Medical Center
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Haverhill, Massachusetts, Forente stater, 01830
- Pentucket Medical Associates
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Missouri
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San Luis, Missouri, Forente stater, 63112
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Cherry Hill, New Jersey, Forente stater, 08034
- Cardiovascular Associates of the Delaware Valley
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New Brunswick, New Jersey, Forente stater, 08903
- Robert Wood Johnson University Hospital
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Sewell, New Jersey, Forente stater, 08080
- Cardiovascular Associates of the Delaware Valley
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New York
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Bronx, New York, Forente stater, 10461
- Jacobi Medical Center
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Bronx, New York, Forente stater, 10457
- Bronx-Lebanon Hospital Center
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Bronx, New York, Forente stater, 10467
- Albert Einstein University Hospital
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Brooklyn, New York, Forente stater, 11215
- New York Methodist Hospital
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Saratoga Springs, New York, Forente stater, 12866
- Saratoga Cardiology Associates
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Forente stater, 28204
- Novant Health Heart and Vascular Institute
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Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center
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Greensboro, North Carolina, Forente stater, 27401
- LeBauer Cardiovascular Research Foundation
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Ohio
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Cincinnati, Ohio, Forente stater, 45267
- University of Cincinnati Medical Center
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Camp Hill, Pennsylvania, Forente stater, 17011
- Capitol Area Research, LLC
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Philadelphia, Pennsylvania, Forente stater, 19102
- Drexel University College of Medicine
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University Hospital
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Pittsburg, Pennsylvania, Forente stater, 15212
- Allegheny-Singer Research Institute
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South Carolina
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Anderson, South Carolina, Forente stater, 29621
- AnMed Health Medical Center
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Texas
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Dallas, Texas, Forente stater, 75390
- University of Texas Southwestern Medical Center Dallas
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Utah
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Murray, Utah, Forente stater, 84157
- Intermountain Medical Center
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Virginia
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Chesapeake, Virginia, Forente stater, 23320
- Cardiovascular Associates, Ltd.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Vanlig omsorg
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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CV Death or Heart Failure Hospitalization
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause Mortality
Tidsramme: 24 months
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All-cause mortality by treatment arm
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24 months
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Cumulative Morbidity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Short Form-36 (SF-36) Vitality Subscale
Tidsramme: 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.
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Baseline, 3, 6, 12 and 24 months
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Resource Utilization
Tidsramme: 24 months
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Observed Resource Use
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24 months
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Resource Utilization Cost
Tidsramme: 24 months
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Observed Hospital-Based Cost.
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24 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael Felker, MD, Duke University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2012
Primær fullføring (Faktiske)
20. september 2016
Studiet fullført (Faktiske)
20. september 2016
Datoer for studieregistrering
Først innsendt
12. september 2012
Først innsendt som oppfylte QC-kriteriene
12. september 2012
Først lagt ut (Anslag)
14. september 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00033097
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .