Please select the eligibility criteria that correspond to the clinical trial below.
Title: C-Pulse Implantable Counterpulsation Pump (ICP) Feasibility Study - A Heart Assist System
Brief Summary: The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.


Options:
A: Inclusion Criteria:

1. DBMD as determined by either a skeletal muscle biopsy demonstrating absence or lack of dystrophin, and/or genetic testing showing a mutation in the dystrophin gene predictive of DBMD, as well as a consistent physical examination
2. Male gender
3. Age greater than or equal to 18 years
4. Cardiac dysfunction with ejection fraction less than or equal to 50% as determined by echocardiogram, cardiac MRI, or multi-gated acquisition (MUGA) scan
5. On a stable dose of ACE-inhibitor or angiotensin receptor blocker (ARB) for at least 3 months; beta-adrenergic receptor blockers and glucocorticosteroids are not required but if used, a stable dose for at least 3 months is required.
6. Ability of the subject or legal guardian to provide informed consent
7. Ability to adhere with study follow-up
8. Willingness to abstain from food and alcohol for 8 hours prior to FMD

Exclusion Criteria:

1. Use of nitrates or alpha-adrenergic receptor blockers
2. Known intolerance or allergy to sildenafil, or a history of any severe allergic or anaphylactic reactions
3. Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable
4. Known hereditary retinal disorder such as retinitis pigmentosa
5. History of priapism or conditions that may predispose to priapism such as sickle cell anemia, multiple myeloma, or leukemia
6. Bleeding disorders
7. Active tobacco use
8. Chronic atrial fibrillation or frequent arrhythmia that would result in an irregular pulse
9. Factors that would preclude obtaining an MRI study - (e.g. implantable pacemaker or cardioverter-defibrillator; body habitus cannot fit into scanner)
10. Systolic blood pressure (SBP) less than 85 mmHg at baseline evaluation
11. Chronic kidney disease stages 4 and 5: GFR\< 30 mL/min/1.73 m2 as determined by serum cystatin C level and the equation eGFRcys = 76.7 x (serum cystatin C-1.18)
12. Current use of sildenafil.
B: Inclusion Criteria:

* DMD patients age 7 years and older (and able to complete cardiac MRI without sedation) with preserved left ventricular (LV) systolic function and abnormal heart muscle by late post-gadolinium imaging (LGE)

Exclusion Criteria:

* renal insufficiency (GFR \<40 mL/min/m2)
* non-MR compatible implants (e.g. neurostimulator, AICD)
* severe claustrophobia
* allergy to gadolinium contrast
* prior use of or known allergy to epleronone
* use of potassium-sparing diuretics
* serum potassium level of \>5.0 mmol/L
C: Inclusion Criteria:

* Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy.
* ACE inhibitor or ARB (Angiotensin Receptor Blocks) at least 30 days preceding implant or nitrate/hydralazine at the investigators discretion
* Beta-blocker for at least 90 days and stable for 30 days preceding implant
* Patient has left ventricular ejection fraction (LVEF) ≤ 35%
* Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrollment or is not indicated for a CRT device
* Patient has had an implanted cardio-defibrillator (ICD) at least 30 days prior to enrollment or is not indicated for ICD implantation.
* Patient is at least 18 years of age and not older than 75 years
* Patient six minute hall walk assessment between 100-350 meters
* Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure

Exclusion Criteria:

* Patient has any evidence of:

  * Ascending aortic calcification on posterior-anterior or lateral chest x-ray at initial screening OR
  * Atherosclerotic ascending aortic disease, specifically intimal thickening greater than 3mm or mobile atheroma (moderate) or mural calcification (severe) as detected by CT scan or echocardiography (Echo)
* Patient has ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or has had an aortic root replacement
* Patient aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm
* Patient has severe mitral valve incompetence, grade 4+
* Patient has moderate to severe aortic valve incompetence, grade 2-4+
* Patient has systolic blood pressure less than 90 or greater than 140 mmHg
* Patient has a Serum Sodium less than 130 mEq/L
* Patient has a Estimated Glomerular Filtration Rate (GFR) less than 40 ml/min/1.73m2
* Patient has any two of three of Bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) greater than three times upper limit of normal
* Patient has a serum Albumin less than 3.0 g/dL
* Patient has Body Mass Index (BMI) less than 18 or greater than 40 kg/m2
* Men with Peak Oxygen Uptake (VO2) of greater than 18 ml/kg/min or less than 10 ml/kg/min OR -Women with Peak VO2 of greater than 16 ml/kg/min or less than 9 ml/kg/min
* Patient has any active infection
* Patient has had a myocardial infarction (MI), stroke, transient ischemic attack (TIA), cardiac or other major surgery, in the 90 days prior to enrollment
* Patient has severe Chronic Obstructive Pulmonary Disease (COPD) as evidenced by Forces Expiratory Volume (FEV1) less than or equal to 0.9 L/min
* Patient requires a concomitant surgical procedure \[i.e. coronary artery bypass graft (CABG), Valve repair\]
* Patient is supported with a left ventricular assist device or IABP
* Severe Right Heart Dysfunction with systemic venous congestion evidenced by clinical signs/symptoms such as Central Venous Pressure (CVP) ≥ 20 mmHg, Cardiac Index (CI) \< 2.0 l/min./m2, elevated liver function tests beyond three time the upper limit of normal and presence of ascites
* Patient has reversible causes of heart failure that may be remedied by conventional surgery or other intervention
* Patient is pregnant; Note: Negative pregnancy test required in all women of child bearing potential
* Patient has any other condition that, in the opinion of the investigators, would disqualify the patient for inclusion in the study, limits survival to less than one year, or not permit valid consideration
* Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound study results
* Patient has symptomatic Carotid artery disease or asymptomatic disease with a stenosis greater than 70%.
D: Inclusion Criteria:

* Duchenne muscular dystrophy patients of all ages
* Null mutation of the dystrophin gene or muscle with \<5% dystrophin
* Doppler echocardiogram with ejection fraction (EF) \<55% within 30 days of enrollment
* Ability to cooperate for testing
* Glucocorticoid treatment acceptable including daily or weekend administration of prednisone or deflazacort

Exclusion Criteria:

* Patients with EF 55% or greater
* Patients with EF \<40% after washout
* Patients taking \>5 mg lisinopril, or \>25 mg losartan or \>5 mg enalapril
* Skeletal deformities or pulmonary anatomical variants that preclude consistent measures of Doppler echocardiography

Answer: C