Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study
Brief Summary: Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability.

It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values.

The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment.


Options:
A: 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
B: Inclusion Criteria:

* Admission because of congestive heart failure
* Elevated NT-proBNP levels on admission

Exclusion Criteria:

* Life-threatening cardiac arrhythmias
* Urgent intervention
* Severe lung disease
* Presence of life threatening disease
* Signed informed consent for other study
* Mental or physical status not allowing written informed consent.
* Unwillingness to give informed consent
* Patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
C: Inclusion Criteria:

* ≥40 Years of age
* with risk factors for LVD including:

  * hypertension (medicated for ≥ 1 month)
  * hypercholesterolemia
  * obesity
  * coronary artery disease (confirmed by angiography)
  * diabetes mellitus
  * arrhythmia
  * valvular abnormalities

Exclusion Criteria:

* failure or unwilling to provide informed consent
* known ventricular dysfunction (confirmed by angiography or echocardiography)
* previous documented episode of heart failure
D: Inclusion Criteria:

* Age \> 21 years of age
* Left ventricular ejection fraction ≤ 40%
* NYHA class II-IV heart failure
* Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion Criteria:

* Severe renal insufficiency defined as serum creatinine \> 2.5 mg/dl
* Inoperable aortic valvular heart disease
* Life expectancy \<1 year due to causes other than HF such as advanced cancer
* Cardiac transplantation or revascularization indicated or expected within 6 months
* Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1S \<1 L when diagnosed as standard of care.
* Subject unable or unwilling to provide written informed consent
* Coronary revascularization (PCI or CABG) within the previous 3 months

Answer: D