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

10 november 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

894

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Gebruikelijke zorg
Gebruikelijke zorg
Experimenteel: 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.
Apparaat: Biomarker-guided care NT-proBNP
Device: NT-proBNP

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CV Death or Heart Failure Hospitalization
Tijdsspanne: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
24 Months

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Duke University

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

  • Hoofdonderzoeker: Michael Felker, MD, Duke University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2012

Primaire voltooiing (Werkelijk)

20 september 2016

Studie voltooiing (Werkelijk)

20 september 2016

Studieregistratiedata

Eerst ingediend

12 september 2012

Eerst ingediend dat voldeed aan de QC-criteria

12 september 2012

Eerst geplaatst (Schatting)

14 september 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 december 2017

Laatste update ingediend die voldeed aan QC-criteria

10 november 2017

Laatst geverifieerd

1 november 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Pro00033097

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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