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

Duke University

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Biomarker-guided care NT-proBNP; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01685840

Pro00033097

Details and patient eligibility

About

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.

Full 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.

Enrollment: 894 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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894 participants in 2 patient groups

Usual Care

Experimental group

Description:

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.

Treatment:

Other: Usual Care

Biomarker-Guided Care

Experimental group

Description:

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.

Treatment:

Device: Biomarker-guided care NT-proBNP