Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pericardiotomy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with Heart Failure with Preserved Ejection Fraction
Arm Description
Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy.
Outcomes
Primary Outcome Measures
Major Adverse Cardiac and Cerebrovascular Events
The number of major cardiac and cerebrovascular events reported.
Change in left ventricular filling pressures during volume loading
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
Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in exercise capacity
Measured by Cardiopulmonary Exercise Testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03923673
Brief Title
Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Official Title
TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Heart Failure with Preserved Ejection Fraction
Arm Type
Experimental
Arm Description
Subjects with Heart Failure with Preserved Ejection Fraction (HFpEF) will receive a minimally invasive treatment called a pericardiotomy.
Intervention Type
Procedure
Intervention Name(s)
Pericardiotomy
Intervention Description
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
Primary Outcome Measure Information:
Title
Major Adverse Cardiac and Cerebrovascular Events
Description
The number of major cardiac and cerebrovascular events reported.
Time Frame
6 months
Title
Change in left ventricular filling pressures during volume loading
Description
The number of subjects to demonstrate an increase in pulmonary capillary wedge pressure in response to volume loading after pericardiotomy vs. prior to pericardiotomy.
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame
baseline, 6 months
Title
Change in exercise capacity
Description
Measured by Cardiopulmonary Exercise Testing
Time Frame
baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry A Borlaug, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
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