NCT03923673已完成不适用
TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac and Cerebrovascular Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Subjects with Heart Failure with Preserved Ejection Fraction
Experimental
Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy.
干预措施: Pericardiotomy (Procedure)
结局指标
主要结局
Major Adverse Cardiac and Cerebrovascular Events
时间窗: 6 months
The number of major cardiac and cerebrovascular events reported.
Change in left ventricular filling pressures during volume loading
时间窗: 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.
次要结局
- Change in Quality of Life(baseline, 6 months)
- Change in exercise capacity(baseline, 6 months)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic
研究点 (1)
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