Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone
Brief Summary: To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.


Options:
A: Inclusion Criteria:

* ≥ 18 years age ≤ 80 years age
* voluntarily signed informed consent
* 15 ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate \< 60 ml/min/1,73 m2
* BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment

Exclusion Criteria:

* p-potassium is \> 5.0 mM
* allergy to contents
* treated with spironolactone
* treated with potent inhibitors of CYP3A4 (see SPC for details)
* treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug
* inborn errors of metabolism (see SPC for details)
* pregnancy or lactation
* fertile woman, not using safe contraception devices
* dementia or other psychiatric disorder, making understanding of the study conditions impossible
* other severe, chronic illness besides CKD, including liver insufficiency, according to investigators' judgement
* vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries
* systolic BP \> 200 mmHg
* immeasurable pulse amplitude
B: Inclusion Criteria:

* Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy
* Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated
* Known kidney damage for \>/= 3 months, as defined by structural or functional abnormalities of the kidney, and

  * Part A: 60 mL/min/1.73 m\*2 \</= eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m\*2 (MDRD, Modification of Diet in Renal Disease) at the screening visit
  * Part B: 30 mL/min/1.73 m\*2 \</= eGFR \<= 60 mL/min/1.73 m\*2 (MDRD) at the screening visit
* Serum potassium \</= 4.8 mmol/L at the screening visit
* Systolic blood pressure \>/= 90 mmHg without signs or symptoms of hypotension at the screening visit

Exclusion Criteria:

* Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only)
* Subjects with anuria, acute renal failure, or Addison's disease
* Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization
* Valvular heart disease requiring surgical intervention during the course of the study
* History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
C: Inclusion Criteria:

* Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
* Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
* Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
* Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
* Subjects with type 2 diabetes mellitus and / or
* Subjects with 30 mL/min/1.73m\^2 \</= eGFR \</= 60 mL/min/1.73m\^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
* Left ventricular ejection fraction (LVEF) \</= 40%
* Blood potassium \</= 5.0 mmol/L at screening
* Systolic blood pressure \>/= 90 mmHg without signs and symptoms of hypotension at the screening visit

Exclusion Criteria:

* Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
* Acute coronary syndrome (ACS) in last 30 days prior to screening
* Cardiogenic shock
* Valvular heart disease requiring surgical intervention during the course of the study
* Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
* Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
D: Inclusion Criteria:

* type 2 diabetes patients with diabetic nephropathy in the range of micro- or macroalbuminuria
* treatment with combination of enalapril and losartan for more than one year

Exclusion Criteria:

* history of non-adherence to prescribed medication assessed by the prescribing physician
* baseline potassium \> 5.5 meq/L
* chronic kidney disease stages 4 or 5
* history or evidence of non-diabetic kidney disease

Answer: C