Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects with Heart Failure with Preserved Ejection Fraction Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy. |
Procedure: Pericardiotomy
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
|
Outcome Measures
Primary Outcome Measures
- Major Adverse Cardiac and Cerebrovascular Events [6 months]
The number of major cardiac and cerebrovascular events reported.
- Change in left ventricular filling pressures during volume loading [baseline, 6 months]
The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
Secondary Outcome Measures
- Change in Quality of Life [baseline, 6 months]
Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Change in exercise capacity [baseline, 6 months]
Measured by Cardiopulmonary Exercise Testing
Eligibility Criteria
Criteria
Inclusion Criteria
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Age ≥ 30 years
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Symptoms of severe dyspnea (III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
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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
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One of the following:
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Previous hospitalization for HF with radiographic evidence (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) of pulmonary congestion or
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Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) or
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Elevated NT-proBNP (>400 pg/ml) or BNP(>200 pg/ml) or
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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
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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:
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Joint, foot, leg, hip or back pain
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Shortness of breath and/or fatigue and/or chest pain
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Unsteadiness or dizziness
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Lifestyle, weather, or I just don't like to be active
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Ambulatory (not wheelchair / scooter dependent)
Exclusion Criteria
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Recent (< 1 month) hospitalization for heart failure
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Left or right ventricular dilatation noted on cardiac imaging study prior to enrollment (either echocardiography or MRI).
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Any hemoglobin (Hgb) < 8.0 g/dl within 30 days prior to randomization
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Any GFR < 20 ml/min/1.73 m2 within 30 days prior to randomization
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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
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Ischemia thought to contribute to dyspnea in the opinion of the investigator
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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)
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PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months
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Obstructive hypertrophic cardiomyopathy
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Known infiltrative cardiomyopathy (amyloid)
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Pericardial disease (constriction, pericarditis, tamponade)
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Active myocarditis
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Complex congenital heart disease
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Active collagen vascular disease
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Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions)
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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
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Terminal illness (other than HF) with expected survival of less than 1 year
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Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
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Inability to comply with planned study procedures
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Pregnancy or breastfeeding mothers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Barry A Borlaug, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 18-010106