Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)
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 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.|
- Time to CV death or HF Hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]Time to CV death or first HF hospitalization
- 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.
|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)|
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685840
|Contact: Gayle Paynter, RN, MBAfirstname.lastname@example.org|
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|Principal Investigator:||Michael Felker, MD||Duke University|