A Study of Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-010106
NCT ID: NCT03923673
Sponsor Protocol Number: 18-010106
About this study
The purpose of this study is to demonstrate acute effectiveness and safety of minimally-invasive pericardiotomy in patients with Heart Failure (HFpEF).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 30 years old.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Barry Borlaug, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available