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

This study has been terminated.
(Project was stopped due to futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685840
First Posted: September 14, 2012
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Heart Failure Other: Usual Care Device: Biomarker-guided care NT-proBNP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • CV Death or Heart Failure Hospitalization [ Time Frame: 24 Months ]
    Composite of First Heart Failure Hospitalization or Cardiovascular Mortality


Secondary Outcome Measures:
  • All-cause Mortality [ Time Frame: 24 months ]
    All-cause mortality by treatment arm

  • Cumulative Morbidity [ Time Frame: 24 months ]
    Days alive and not hospitalized for CV reasons

  • CV Death [ Time Frame: 24 months ]
    CV death by treatment arm

  • Number of Hospitalizations for First Heart Failure [ Time Frame: 24 months ]
    First Heart Failure Hospitalization

  • Number of Hospitalizations for Recurrent Heart Failure [ Time Frame: 24 months ]
    Recurrent Heart Failure Hospitalization

  • 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.


  • 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).

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Resource Utilization [ Time Frame: 24 months ]
    Observed Resource Use

  • Resource Utilization Cost [ Time Frame: 24 months ]
    Observed Hospital-Based Cost.


Enrollment: 894
Study Start Date: December 2012
Study Completion Date: September 20, 2016
Primary Completion Date: September 20, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685840


  Show 46 Study Locations
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael Felker, MD Duke University