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

10 november 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

894

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Vanlig vård
Vanlig vård
Experimentell: 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.
Enhet: Biomarker-guided care NT-proBNP
Device: NT-proBNP

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CV Death or Heart Failure Hospitalization
Tidsram: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
24 Months

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Utredare

  • Huvudutredare: Michael Felker, MD, Duke University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2012

Primärt slutförande (Faktisk)

20 september 2016

Avslutad studie (Faktisk)

20 september 2016

Studieregistreringsdatum

Först inskickad

12 september 2012

Först inskickad som uppfyllde QC-kriterierna

12 september 2012

Första postat (Uppskatta)

14 september 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2017

Senast verifierad

1 november 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00033097

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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