Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial
Brief Summary: The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.


Options:
A: Inclusion Criteria:

* They must be at least 18 years of age.
* They must understand the study purpose and give their written informed consent.
* They must have been stable on chronic hemodialysis for at least three months before enrollment into the study.
* Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction.

Exclusion Criteria:

* Subjects with primary operable valvular heart disease.
* Subjects with a congenital heart disease.
* Subjects with unstable angina.
* Subjects with primary hepatic failure.
* Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease).
* Subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible.
* Subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis.
* Subjects with habitually difficult to control hyperkalemia (serum potassium \>6.0 meq/L) in the previous month while on dialysis will be excluded.
* The inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.
B: Inclusion Criteria:

* Age \> 18
* Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria:

* Pregnancy
* Hiperkalemia (K\> 5.5meq/l)
* Intolerance to spironolactone
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:

1. Maintenance hemodialysis therapy for end-stage renal disease
2. Age 18-85 years
3. ≥3 calendar months since dialysis initiation. Note if a patient has been on dialysis for ≥3 but less than 6 calendar months, there must be no hospitalizations during the 6 weeks prior to screening, and no change in estimated dry weight (EDW) within 2 weeks of the screening date.
4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug.
5. Ability to provide informed consent

Exclusion Criteria:

1. Serum potassium ≥6.5 mEq/L within the 3 months prior to screening
2. Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test.
3. Unscheduled dialysis for hyperkalemia within the 3 months prior to screening
4. Pre-dialysis systolic blood pressure \<100 mm Hg within 2 weeks prior to screening or at the baseline visit
5. 2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure \<80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension
6. Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)
7. Current use of digoxin
8. Current use of spironolactone or eplerenone
9. Allergy to spironolactone
10. Inability to maintain dialysis machine blood flow ≥300 mL/min during any of the most recent 3 dialysis sessions prior to the screening visit as an indicator of vascular access dysfunction
11. Mitral valve repair or replacement
12. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging
13. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
14. Expected survival \<9 months
15. Pregnancy, anticipated pregnancy, or breastfeeding
16. Incarceration
17. Participation in another intervention study

Answer: D