Brief 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.
Brief Title
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
Detailed 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Heart Failure
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01685840
Org Class
Other
Org Full Name
Duke University
Org Study Id
Pro00033097
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Primary Outcomes
Outcome Description
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
Outcome Measure
CV Death or Heart Failure Hospitalization
Outcome Time Frame
24 Months
Secondary Outcomes
Outcome Description
All-cause mortality by treatment arm
Outcome Time Frame
24 months
Outcome Measure
All-cause Mortality
Outcome Description
Days alive and not hospitalized for CV reasons
Outcome Time Frame
24 months
Outcome Measure
Cumulative Morbidity
Outcome Description
CV death by treatment arm
Outcome Time Frame
24 months
Outcome Measure
CV Death
Outcome Description
First Heart Failure Hospitalization
Outcome Time Frame
24 months
Outcome Measure
Number of Hospitalizations for First Heart Failure
Outcome Description
Recurrent Heart Failure Hospitalization
Outcome Time Frame
24 months
Outcome Measure
Number of Hospitalizations for Recurrent Heart Failure
Outcome Description
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.
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.
Outcome Time Frame
Baseline, 3,6, 12 and 24 months
Outcome Measure
Percentage of Patients With Moderate to Severe Depression
Outcome Description
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).
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
Duke Activity Status Index (DASI)
Outcome Description
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).
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
EQ-5D Health Index
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
EQ-5D Visual Analog Scale
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6,12 and 24 months
Outcome Measure
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
Short Form-36 (SF-36) General Health Subscale
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
Short Form-36 (SF-36) Mental Health Subscale
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
Short Form-36 (SF-36) Social Functioning Subscale
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
Short Form-36 (SF-36) Physiological Functioning Subscale
Outcome Description
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.
Outcome Time Frame
Baseline, 3, 6, 12 and 24 months
Outcome Measure
Short Form-36 (SF-36) Vitality Subscale
Outcome Description
Observed Resource Use
Outcome Time Frame
24 months
Outcome Measure
Resource Utilization
Outcome Description
Observed Hospital-Based Cost.
Outcome Time Frame
24 months
Outcome Measure
Resource Utilization Cost
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ileana Pina
Investigator Email
ILPINA@montefiore.org
Investigator Phone