Please select the eligibility criteria that correspond to the clinical trial below.
Title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Brief Summary: The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).


Options:
A: Inclusion Criteria:

* Participant who is willing and able to give informed consent for participation in the study.
* Male or Female, aged 60 years and over (Group 1, Oxford).
* Patients diagnosed with HFNEF by ESC criteria and have peak V02 ≤ 85% with a cardiac pattern of exercise limitation during CPEX (Group 1, Oxford).
* Hypertensive controls aged 65 and over without HFNEF and with peak V02 \> 90% (Group 2, Aberdeen)
* Able to perform exercise testing.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* LVEF \<50%
* Inability to tolerate MRI scanning (claustrophobia, inability to lie flat)
* Contraindications to CMR imaging (implantable devices or other metal implants, internal cardioverter-defibrillator, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium)
* Presence of other significant concomitant diseases such as ischaemic, valvular, pericardial heart disease or cardiomyopathy.
* Presence of asthma (contraindication to adenosine)
* Presence of 2nd or 3rd degree AV block (contraindications to ivabradine and adenosine)
* Presence of sick sinus syndrome
* Presence of atrial fibrillation
* Significant bradycardia (HR \<60 per minute).
* Objective evidence of lung disease on formal lung function testing
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study
* Unable to perform exercise testing
* Patient who is in terminally ill or is inappropriate for medication
* Known hypersensitivity to Ivabradine or adenosine
* Significantly impaired renal function (eGFR\<30ml/min)
B: Inclusion Criteria:

* Age greater than or equal to 18 years.
* Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization.

The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (\>1+); or c) dyspnea.

* NYHA Class III or IV at the time of hospitalization.
* Left Ventricular Ejection Fraction \< = 40% within one year.

Exclusion Criteria

* Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form.
* Positive urine pregnancy test.
* Inability to provide written informed consent.
* Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions.
* Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
* Subjects who are on cardiac mechanical support.
* History of bi-ventricular pacer placement within the last 60 days.
* Co-morbid condition with an expected survival less than six months.
* Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization.
* History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
* History of a cerebrovascular accident within the last 30 days.
* Hemodynamically significant uncorrected primary cardiac valvular disease.
* Hypertrophic cardiomyopathy (obstructive or non-obstructive).
* CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
* Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes.
* History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
* History of poorly controlled diabetes mellitus.
* Morbid obesity, defined as \> 159 kg (or 350 lbs) or BMI \> 40.
* Supine systolic arterial blood pressure \< 90 mmHg.
* Serum creatinine \> 3.5 mg/dL or \> 309.4 mmol/L.
* Serum potassium \> 5.5 mEq/L or \> 5.5 mmol/L.
* Hemoglobin \< 9 g/dL or \< 90 g/L.
* History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril).
* History of drug or medication abuse within the past year, or current alcohol abuse.
* Inability to take oral medications.
* Participation in another clinical drug or device trial within the past 30 days.
* Previous participation in this or any other tolvaptan clinical trial.
C: Inclusion Criteria:

* Coronary artery disease
* Left ventricular systolic dysfunction
* Sinus rhythm: heart rate (HR) \>= 60 beats per minute (bpm)

Exclusion Criteria:

* Unstable cardiovascular condition
* Severe congestive heart failure
D: Inclusion Criteria:

* History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional Class II and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ACE-I/ARBs; beta-blockers) and diuretics if indicated for fluid overload. Should have participated in the double-blind phase of the EMPHASIS-HF trial

Exclusion Criteria:

* Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2.

Answer: B