Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

Heart Failure Clinical Trial

— GUIDE-IT  

Official title:

Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01685840
• Other study ID #: Pro00033097
• Status: Terminated
• Phase: N/A
• First received: September 12, 2012
• Last updated: November 10, 2017
• Start date: December 2012
• Est. completion date: September 20, 2016

Study information

• Verified date: November 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 894
• Est. completion date: September 20, 2016
• Est. primary completion date: September 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Usual Care
Usual Care

Device:
• Biomarker-guided care NT-proBNP
Device: NT-proBNP

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Michaels Hospital	Toronto	Ontario
Canada	Saint Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	AnMed Health Medical Center	Anderson	South Carolina
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	University of Maryland	Baltimore	Maryland
United States	Metropolitan Cardiovascular Consultants	Beltsville	Maryland
United States	Beth Israel Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Albert Einstein University Hospital	Bronx	New York
United States	Bronx-Lebanon Hospital Center	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	New York Methodist Hospital	Brooklyn	New York
United States	Capitol Area Research, LLC	Camp Hill	Pennsylvania
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	Cardiovascular Associates of the Delaware Valley	Cherry Hill	New Jersey
United States	Cardiovascular Associates, Ltd.	Chesapeake	Virginia
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Holy Cross Medical Group	Coral Springs	Florida
United States	University of Texas Southwestern Medical Center Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	The Heart Center PC	Huntsville	Alabama
United States	Krannert Institute of Cardiology	Indianapolis	Indiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Intermountain Medical Center	Murray	Utah
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Allegheny-Singer Research Institute	Pittsburg	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Sutter Memorial Hospital	Sacramento	California
United States	University of California San Diego Medical Center	San Diego	California
United States	Washington University School of Medicine	San Luis	Missouri
United States	Saratoga Cardiology Associates	Saratoga Springs	New York
United States	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CV Death or Heart Failure Hospitalization	Composite of First Heart Failure Hospitalization or Cardiovascular Mortality	24 Months
Secondary	All-cause Mortality	All-cause mortality by treatment arm	24 months
Secondary	Cumulative Morbidity	Days alive and not hospitalized for CV reasons	24 months
Secondary	CV Death	CV death by treatment arm	24 months
Secondary	Number of Hospitalizations for First Heart Failure	First Heart Failure Hospitalization	24 months
Secondary	Number of Hospitalizations for Recurrent Heart Failure	Recurrent Heart Failure Hospitalization	24 months
Secondary	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.	Baseline, 3,6, 12 and 24 months
Secondary	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).	Baseline, 3, 6, 12 and 24 months
Secondary	EQ-5D Health Index	The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).	Baseline, 3, 6, 12 and 24 months
Secondary	EQ-5D Visual Analog Scale	The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.	Baseline, 3, 6, 12 and 24 months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score	This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.	Baseline, 3, 6,12 and 24 months
Secondary	Short Form-36 (SF-36) General Health Subscale	SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.	Baseline, 3, 6, 12 and 24 months
Secondary	Short Form-36 (SF-36) Mental Health Subscale	SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.	Baseline, 3, 6, 12 and 24 months
Secondary	Short Form-36 (SF-36) Social Functioning Subscale	SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.	Baseline, 3, 6, 12 and 24 months
Secondary	Short Form-36 (SF-36) Physiological Functioning Subscale	SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.	Baseline, 3, 6, 12 and 24 months
Secondary	Short Form-36 (SF-36) Vitality Subscale	SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.	Baseline, 3, 6, 12 and 24 months
Secondary	Resource Utilization	Observed Resource Use	24 months
Secondary	Resource Utilization Cost	Observed Hospital-Based Cost.	24 months