REDUCE LAP-HF TRIAL

Key Inclusion Criteria:

• Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

• New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
• One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
• On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
• Age ≥ 40 years old
• Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
• Elevated left ventricular filling pressures with a gradient compared to CVP documented by :

• PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
• PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg

Key Exclusion Criteria:

• Severe heart failure defined as:

• ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
• Fick Cardiac Index < 2.0 L/min/m2
• Requiring inotropic infusion (continuous or intermittent) within the past 6 months
• Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS