Please select the eligibility criteria that correspond to the clinical trial below.
Title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Brief Summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).


Options:
A: Inclusion Criteria:

* Diagnosis of Major Depressive Disorder
* Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
* 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
* Sedentary lifestyle
* Physically capable of exercise
* Body mass index (BMI) less than 40 kg/m2
* Willing and able to comply with study requirements

Exclusion Criteria:

* Significant cardiovascular disease or other medical conditions
* Uncontrolled hypertension
* Abnormal exercise stress test
* Hematologic disorders
* Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
* Alcohol and/or substance abuse in the past 6 months
* Hospitalization for mental illness within the past year
* High suicide risk
* Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
* Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
* Significantly elevated blood lipids
* Pregnancy
B: Inclusion Criteria:

* DSM-IV diagnosis of major depressive disorder (MDD)
* Score of greater than 11 on the Beck Depression Inventory (BDI)

Exclusion Criteria:

* Primary psychiatric diagnosis other than major depressive disorder (e.g., bipolar disorder)
* Any of the following DSM-IV diagnoses: dementia or delirium; obsessive compulsive disorder (OCD); schizophrenia, schizoaffective, or other psychotic disorder; psychotic features, including any delusions or hallucinations during the current depressive episode; current alcohol or other substance abuse disorder; acute risk for suicide (e.g., score of greater than 2 on the suicide item on the HAM-D) or acute risk for homicide
* May require treatment with additional psychotherapeutic agents (other than chloral hydrate for sleep) during the course of the study
* Significant medical conditions that may cause an increased risk for a significant adverse experience during the course of the trial (e.g., unstable angina, myocardial infarction within 3 months of study entry, etc.)
* Unable to be randomly assigned to the study drug due to a risk for adverse cardiac events, such as prolonged QT interval, use of other medications that would be counterindicated for use with sertraline, or other conditions that may make study participation unsafe
* Unable to be randomly assigned to an exercise condition due to medical conditions such as musculoskeletal problems or abnormal cardiac response to exercise (e.g., exercise-induced ventricular tachycardia, abnormal blood pressure response, etc.)
* Currently receiving antidepressant medication or actively engaged in psychotherapy
* Currently exercising regularly
C: Inclusion Criteria:

* LVEF less than or equal to 35%
* New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment
* Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment
* Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry
* Must be in stable medical condition and able to begin an exercise program, as determined by study physician

Exclusion Criteria:

* Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training
* Pregnant or planning to become pregnant in the year following study entry
* Major heart event or heart procedure within the 6 weeks prior to study entry
* Heart procedure or hospitalization for any reason planned in the future
* Expecting to receive a heart transplant in the 6 months following study entry
* CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure
* CHF caused by congenital heart disease or obstructive cardiomyopathy
* Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry
* Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia
* Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training
* Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure)
* Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed
* Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality
D: Inclusion Criteria:

* Persistent depressive symptoms that may include the following: depressed mood; diminished interest or pleasure in activities; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or inappropriate guilt; diminished ability to think or concentrate; or recurrent thoughts of death or suicidal ideations
* Documented history of coronary heart disease (i.e., a prior heart attack, coronary artery bypass graft, or greater than 75% stenosis in at least one coronary artery)

Exclusion Criteria:

* Experienced an acute heart attack or any revascularization procedure (i.e., CABG or percutaneous transluminal coronary angioplasty) within 60 days of study entry
* Left ventricular ejection fraction \<30% with labile ECG changes prior to testing
* Currently using a pacemaker
* Resting blood pressure greater than 160/100 mmHg
* Left main disease \>50%
* Failure to meet our criteria for depression or achieve a score of ≥9 on the Beck Depression Inventory-II
* Any other concurrent psychiatric intervention
* Primary psychiatric diagnosis other than Major or Minor Depressive Episode
* Primary diagnosis of the following psychiatric disorders: schizophrenia, bipolar disorder, schizoaffective disorder, other psychotic disorder, dementia, current delirium, current obsessive compulsive disorder
* Experienced psychotic symptoms during the current depressive episode
* Current abuse or dependence on alcohol or other drugs
* Acute suicide risk
* Patients who, during the course of the study, would likely require treatment with additional psychotherapeutic agents
* Significant medical conditions that would make exercise or sertraline use medically inadvisable (e.g., unstable angina, heart attack within the 3 months prior to study entry, musculoskeletal problems, or congestive heart failure)
* Abnormal thyroid-stimulating hormone (TSH) level and glucose level greater than or equal to 126 mg/dL
* Patients who would not be able to be randomized to either the drug (e.g., adverse cardiac events such as prolonged QT interval, allergic responses) or exercise (e.g., musculoskeletal problems, abnormal cardiac response to exercise, such as exercise-induced VT, abnormal blood pressure response, etc.)
* Currently using medications that would make exercise or sertraline use medically inadvisable (e.g., clonidine, dicumarol, warfarin, anticonvulsants, or MAO inhibitors)
* Current uncontrolled medical condition that could be causing the depressive symptoms (e.g., thyroid dysfunction, anemia)
* Pregnant, planning to get pregnant during the study period, or lactating
* Herbal supplements with purported mood effects (e.g., St. John's wort, valerian, gingko)
* Current use of antidepressant medication
* Currently participating in psychotherapy
* Currently participating in regular aerobic exercise
* Documented failure to respond to sertraline therapy

Answer: C