minimally invasive pericardiotomy as a new treatment for heart failure

Conditions: Heart Failure

Summary: researchers are studying the safety and efficacy of a minimally invasive treatment called a pericardiotomy, which creates a small opening in the sac that surrounds the heart. researchers will test the short and long term effects of this procedure by monitoring subjects heart function and symptoms.


Eligibility criteria:
inclusion criteria * age ≥ 30 years * symptoms of severe dyspnea (iii-iv) without evidence of a non-cardiac or ischemic explanation for dyspnea * ef of \> or = 50% determined on most recent imaging study within the preceding 5 years, with no change in clinical status suggesting potential for deterioration in systolic function * one of the following: * previous hospitalization for hf with radiographic evidence (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) of pulmonary congestion or * catheterization documented elevated filling pressures at rest (pcwp ≥15 or lvedp ≥18) or with exercise (pcwp ≥25) or * elevated nt-probnp (\>400 pg/ml) or bnp(\>200 pg/ml) or * echo evidence of diastolic dysfunction/elevated filling pressures manifest by medial e/e' ratio≥15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure * heart failure is primary factor limiting activity as indicated by answering # 2 to the following question: my ability to be active is most limited by: * joint, foot, leg, hip or back pain * shortness of breath and/or fatigue and/or chest pain * unsteadiness or dizziness * lifestyle, weather, or i just don't like to be active * ambulatory (not wheelchair / scooter dependent) exclusion criteria * recent (\< 1 month) hospitalization for heart failure * left or right ventricular dilatation noted on cardiac imaging study prior to enrollment (either echocardiography or mri). * any hemoglobin (hgb) \< 8.0 g/dl within 30 days prior to randomization * any gfr \< 20 ml/min/1.73 m2 within 30 days prior to randomization * significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator * ischemia thought to contribute to dyspnea in the opinion of the investigator * acute coronary syndrome within 3 months defined by electrocardiographic (ecg) changes and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent) * pci, coronary artery bypass grafting, or new biventricular pacing within past 3 months * obstructive hypertrophic cardiomyopathy * known infiltrative cardiomyopathy (amyloid) * pericardial disease (constriction, pericarditis, tamponade) * active myocarditis * complex congenital heart disease * active collagen vascular disease * significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions) * acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, inr \> 1.7 in the absence of anticoagulation treatment * terminal illness (other than hf) with expected survival of less than 1 year * enrollment or planned enrollment in another therapeutic clinical trial in next 3 months. * inability to comply with planned study procedures * pregnancy or breastfeeding mothers