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

This study is currently recruiting participants.
Verified October 2013 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01685840
First received: September 12, 2012
Last updated: October 16, 2013
Last verified: October 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Time to CV death or HF Hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to CV death or first HF hospitalization


Secondary Outcome Measures:
  • Time to All-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to death

  • Cumulative Morbidity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time alive and not hospitalized for CV reasons

  • Time to Death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to CV death

  • Time to first HF hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time to first HF hospitalization

  • Health Related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health related quality of life

  • Resource Utilization, cost and cost effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    medical costs, resource and cost effectiveness

  • Number of participants with AEs of interest and/ or SAEs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of participants with Adverse Events of interest and/ or Serious Adverse Events.


Estimated Enrollment: 1100
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Hospitalization for acute decompensated HF, manifest by Dyspnea at rest or on minimal exertion plus At least 1 sign of volume overload:
  • Elevated jugular venous pulse
  • Pulmonary rates
  • Peripheral edema
  • Congestion on chest x-ray
  • Most recent documented LVEF to be ≤ 40% by any method within 12 months of randomization. This assessment must occur at least 12 weeks after any intervention likely to improve ejection fraction (e.g., cardiac resynchronization therapy, initiation of beta-blocker therapy, or revascularization).
  • NT-ProBNP > 2000 pg/mL at least once during index hospitalization
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685840

Contacts
Contact: Gayle Paynter, RN, MBA 919-668-8641 gayle.e.paynter@duke.edu

  Show 41 Study Locations
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Michael Felker, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01685840     History of Changes
Other Study ID Numbers: Pro00033097
Study First Received: September 12, 2012
Last Updated: October 16, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Duke University:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014