Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

10 novembre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

894

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Solita cura
Solita cura
Sperimentale: 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.
Dispositivo: Biomarker-guided care NT-proBNP
Device: NT-proBNP

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CV Death or Heart Failure Hospitalization
Lasso di tempo: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
24 Months

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Duke University

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Investigatori

  • Investigatore principale: Michael Felker, MD, Duke University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2012

Completamento primario (Effettivo)

20 settembre 2016

Completamento dello studio (Effettivo)

20 settembre 2016

Date di iscrizione allo studio

Primo inviato

12 settembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2012

Primo Inserito (Stima)

14 settembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 dicembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 novembre 2017

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00033097

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Arresto cardiaco

Prove cliniche su Solita cura

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Tunisia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi