GUIDE-ITBiomarker-Guided Heart Failure Therapy Using NT-proBNP
This study aims to guide heart failure therapy using a biomarker called NT-proBNP, with the primary goal of reducing either your first heart failure hospitalization or cardiovascular mortality.
Usual Care
+ Biomarker-guided care NT-proBNP
Cardiovascular Diseases
+ Heart Diseases
+ Heart Failure
Treatment Study
Summary
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.894 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 46 locations
Sutter Memorial Hospital
Sacramento, United StatesUniversity of California San Diego Medical Center
San Diego, United StatesYale University School of Medicine
New Haven, United States