Please select the eligibility criteria that correspond to the clinical trial below.
Title: Aldosterone BloCkade for Health Improvement EValuation in End-stage Renal Disease
Brief Summary: Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis.

Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients.

The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.


Options:
A: Inclusion Criteria:

The series will consist of:

1. Patients with at least 18 years of age,
2. Suffering from chronic kidney disease stage V on dialysis,
3. Mean blood pressure residential than 135 x 85 mm Hg and
4. Who present left ventricular mass indexed for height to the 2.7 power greater than 51 g/m2, 7.

Exclusion Criteria:

1. History or evidence of angina or myocardial infarction,
2. Heart failure,
3. Peripheral vascular disease,
4. Hyperkalemia
5. Previous valve atrial fibrillation,
6. Anemia (hemoglobin \<10 g/dl),
7. Doses of parathyroid hormone (PTH) greater than 300 pg/mL,
8. Patients being treated with spironolactone and
9. Patients who have suspended or initiated the use of inhibitors of angiotensin converting enzyme inhibitors, angiotensin receptor blockers (ARBs) renin blockers in the last six months.
B: Inclusion Criteria:

1. Age

   1. ≥45 years or
   2. ≥18 with a history of diabetes
2. On dialysis ≥ 90 days
3. On either

   1. Hemodialysis prescribed at least 2 treatments per week or
   2. Peritoneal dialysis prescribed with at least 1 exchange daily
4. Provides informed consent

Exclusion Criteria:

1. Hyperkalemia

   1. Serum potassium \>5.8 mmol/L in the 6 weeks prior to enrollment or
   2. Serum potassium \>6.0 mmol/L during active run-in
2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
3. Known sensitivity or allergy to spironolactone
4. Current or planned pregnancy or breastfeeding
5. Scheduled living related donor renal transplant
6. Life expectancy \< 6 months in the opinion of a treating nephrologist.
7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated
C: Inclusion Criteria:

* Written informed consent.
* Adult men and women on HD for at least 45 days for ESRD regardless of the etiology including diabetes, with at least 3 HD sessions per week
* Presenting at least one of the follow comorbidities, cardiovascular abnormalities or CV risk factors:
* Left ventricular hypertrophy defined by left ventricular mass \> 130 g/m2 in men and 100 g/m2 in women (echocardiography)
* OR Cornell (RaVL + SV3) \>28 mm in men, \> 20 mm in women(ECG)
* OR left ventricular ejection fraction \< 40%
* OR large QRS \> 0.14 sec
* OR Left bundle branch block (ECG) measured during the twelve months preceding inclusion; diabetes;
* OR history of cardiovascular disease: coronary artery disease, symptomatic lower limb peripheral arterial disease, carotid or renal artery stenosis \> 50%, stroke, hospitalization for heart failure, permanent atrial fibrillation (AF), oral anticoagulant treatment for AF, valvular heart prosthesis,
* OR CRP \> 5 mg/l for 3 months without infectious or neoplastic disease documented in progress

Exclusion Criteria:

* history of hypersensitivity to spironolactone or galactose intolerance
* the Lapp lactase deficiency or malabsorption of glucose or galactose
* hyperkalemia \> 5.5 mmol/l during the two weeks prior to enrolment
* history of unscheduled hemodialysis for hyperkalemia during the last six months
* hospitalization for hyperkalemia during the last six months
* patients with imperative indication of a combination of ACEI and sartan or renin inhibitor (each being authorized separately), NSAIDS, Cox-2 inhibitors
* kidney transplant scheduled within the year
* symptomatic interdialytic hypotension
* acute systemic disease
* uncompensated hypothyroidism
* acute hyperthyroidism
* any prior or concomitant clinical condition compromising the inclusion, in the discretion of the investigator
* cardiac transplant
* severe uncontrolled arrhythmia
* stroke within 3 months prior to enrolment
* acute coronary syndrome in the previous month inclusion
* recent (1 month) or planned coronary revascularization by angioplasty
* recent (3 months) or planned cardiovascular surgery (excluding HD vascular access)
* non menopausal women or without effective contraceptive methods
* pregnancy, breastfeeding or planning a pregnancy within 2 years
* non compliance
* protected adult
* SBP \> 200 mmHg and/or DBP \> 110 mmHg
* Concomitant treatment can not be stopped by another potassium-sparing diuretic, a potassium supplements, AINS or Cox 2 inhibitors
D: Inclusion Criteria:

* Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
* With an average serum potassium level (immediately before dialysis on the first day of the week) of \<6.5 mEq/l over the previous 2 months
* With a 24-hour urine output of \<500 ml

Exclusion Criteria:

* A history of noncompliance
* Unstable vascular access
* Hypotension
* Hepatic failure
* Active cancer
* Any life-threatening disease other than ESRD

Answer: B