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

November 10, 2017 updated by: 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

894

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Usual Care
Usual Care
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.
Device: Biomarker-guided care NT-proBNP
Device: NT-proBNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CV Death or Heart Failure Hospitalization
Time Frame: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
24 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michael Felker, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 20, 2016

Study Completion (Actual)

September 20, 2016

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00033097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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