Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of L-arginine and Spironolactone in Dialysis-dependant End Stage Renal Disease
Brief Summary: Cardiovascular disease is the primary cause of death in patients with end stage renal disease (ESRD). New research suggests that the high risk of death may be partly due to high levels of fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent ESRD. This study is designed to compare the effects of two different drugs, spironolactone and L-arginine, with placebo on structure and function of the heart in individuals with dialysis-dependent ESRD.


Options:
A: 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
B: Inclusion Criteria:

* Chronic dialysis therapy for End Stage Renal Disease
* Age 21-85

Exclusion Criteria:

* Hyperkalemia requiring unscheduled dialysis within 3 months
* Pre-dialysis potassium ≥6.5 meq/L within 3 months
* Hypotension defined as SBP \<100
* Recurrent intra-dialytic hypotension defined as recurrent cramping, light-headedness, or hypotension requiring infusion of saline or other intervention or otherwise limiting ability to achieve dry weight. Or SBP \<80
* History of myocardial infarction
* History of coronary artery bypass surgery
* Non revascularized coronary disease \>90%
* Mitral valve repair or replacement
* Severe mitral valve disease
* Renal transplant expected within 9 months
* Expected survival \< 9 months
* Pregnant
* Prisoners
* Unable to provide consent
* Allergy to spironolactone or L-arginine
* Digitalis use
* 1st or 2nd degree heart block
C: Inclusion Criteria:

* Age \>18 years
* Hemodialysis treatment for at least 3 months
* At least 3 dialysis sessions per week
* Written informed consent

Exclusion Criteria:

* Contraindications for cardiac magnet resonance imaging (CMR)
* Mineralocorticoid receptor antagonist treatment within the last 6 months
* Estimated life expectancy \< 12 months as judged by the nephrologist
* History of hyperkalemia, defined as pre-dialysis potassium \> 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
* High risk to develop hyperkalemia defined as pre-dialysis potassium \> 6.0 mmol/l
* Hypotension (systolic blood pressure \< 100 mmHg)
* Planned kidney transplantation (living donor) within the prospected study duration
* Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
* Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
* Allergy/hypersensitivity to spironolactone
* Non-compliance suspected or demonstrated
D: 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.

Answer: B