Please select the eligibility criteria that correspond to the clinical trial below.
Title: BOLD: A Trial of Blood Pressure Lowering in Dialysis
Brief Summary: Blood pressure may be one of the most important modifiable risk factors for cardiovascular disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis. Although a systolic blood pressure \<140 mmHg treatment target has been recommended, there remains uncertainty on which blood pressure should be targeted, more specifically that measured in the dialysis unit or at home. Observational studies have reported a paradoxical U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with poor outcomes). Conversely, the same studies have reported a linear association between higher home systolic blood pressure and worse clinical outcomes, where blood pressure below 140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this important question.


Options:
A: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Undergoing in-center, thrice weekly hemodialysis for treatment of end-stage-renal-disease
3. Greater than 3 months since initiation of dialysis
4. Age 18 years or above
5. Able to obtain a brachial blood pressure at dialysis and at home

Exclusion Criteria:

1. Pregnancy, anticipated pregnancy, or breastfeeding as this will require increase to more than three time a week dialysis and/or preclude use of some classes of blood pressure medications
2. Incarceration or institutionalized living which may prohibit measurement of home blood pressure
3. Participation in another intervention study that may affect blood pressure
4. Patients in whom systolic blood pressure is not measurable (e.g. those with left ventricular assist devices)
5. Hypotension: average pre-dialysis systolic blood pressure \<100 mmHg over last 2 weeks prior to screening while not taking any blood pressure medications
6. Life expectancy \<4 months
7. Anticipated living donor kidney transplant within 4 months
B: Inclusion Criteria:

* Hemoglobin less than or equal to 11 g/dL
* History of Chronic Kidney Disease
* eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
* Tsat (transferrin saturation) greater than 15%

Exclusion Criteria:

* Uncontrolled hypertension
* Erythropoietic protein use within 12 weeks of randomization
C: Inclusion Criteria:

* Patients currently receiving maintenance hemodialysis
* Patients with depression and/or anxiety as indicated by scores of ≥10 on the Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder-7 (GAD- 7)
* Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test)

Exclusion Criteria:

* Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
* Acute psychotic symptoms
* Acute Suicidal ideation/intent
D: Inclusion Criteria:

* Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months
* Able to speak English
* ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months

Exclusion Criteria:

* Severe cognitive impairment on Mini-COG cognitive test (score \< 3)
* Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9
* Suicidal Ideation
* Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score \> 5)
* Severe restless leg syndrome
* Treatment with trazodone in the past one month
* Known allergy to trazodone (self-report or by chart review)
* Current treatment with monoamine oxidase inhibitors or in the preceding 14 days
* Current treatment with linezolid (self-report or by chart review)
* Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics
* Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control
* Life Expectancy \< 3 months
* Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months
* Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial

Answer: A