Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

Duke University894 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

894

Conditions

Heart Failure

Interventions

Usual CareOTHER

Usual Care

Biomarker-guided care NT-proBNPDEVICE

Device: NT-proBNP

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

CV Death or Heart Failure Hospitalization

Composite of First Heart Failure Hospitalization or Cardiovascular Mortality

Time frame: 24 Months

Secondary Outcomes

All-cause Mortality

All-cause mortality by treatment arm

Time frame: 24 months

Cumulative Morbidity

Days alive and not hospitalized for CV reasons

Time frame: 24 months

CV Death

CV death by treatment arm

Time frame: 24 months

Number of Hospitalizations for First Heart Failure

First Heart Failure Hospitalization

Time frame: 24 months

Number of Hospitalizations for Recurrent Heart Failure

Recurrent Heart Failure Hospitalization

Time frame: 24 months

Percentage of Patients With Moderate to Severe Depression

Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.

Time frame: Baseline, 3,6, 12 and 24 months

Duke Activity Status Index (DASI)

The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).

Data from ClinicalTrials.gov

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Yale University School of Medicine

New Haven, Connecticut, United States

Holy Cross Medical Group

Coral Springs, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Emory University

Atlanta, Georgia, United States

University Cardiology Associates, LLC

Augusta, Georgia, United States

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, United States

Krannert Institute of Cardiology

Indianapolis, Indiana, United States

...and 36 more locations