Suspended

GUIDE-ITBiomarker-Guided Heart Failure Therapy Using NT-proBNP

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

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.

What is being tested

Usual Care

+ Biomarker-guided care NT-proBNP

OtherDevice
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorDuke University
Last updated: December 12, 2017
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorDuke University
Last updated: December 12, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

894 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cardiovascular DiseasesHeart DiseasesHeart Failure

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study 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

The Heart Center PC

Huntsville, United StatesOpen The Heart Center PC in Google Maps

Sutter Memorial Hospital

Sacramento, United States

University of California San Diego Medical Center

San Diego, United States

Yale University School of Medicine

New Haven, United States
Suspended46 Study Centers