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出境医 / 临床实验 / Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure

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
Heart Failure Procedure: Pericardiotomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022
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 :
  1. Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: 6 months ]
    The number of major cardiac and cerebrovascular events reported.

  2. Change in left ventricular filling pressures during volume loading [ Time Frame: 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 :
  1. Change in Quality of Life [ Time Frame: baseline, 6 months ]
    Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)

  2. Change in exercise capacity [ Time Frame: baseline, 6 months ]
    Measured by Cardiopulmonary Exercise Testing


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Barry A Borlaug, MD Mayo Clinic
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: 6 months ]
    The number of major cardiac and cerebrovascular events reported.
  • Change in left ventricular filling pressures during volume loading [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Change in Quality of Life [ Time Frame: baseline, 6 months ]
    Measured using Kansas City Cardiomyopathy Questionnaire (KCCQ)
  • Change in exercise capacity [ Time Frame: baseline, 6 months ]
    Measured by Cardiopulmonary Exercise Testing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure
Official Title  ICMJE TtP: Minimally Invasive Pericardiotomy as a New Treatment for Heart Failure (Transform the Practice)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Procedure: Pericardiotomy
The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
Study Arms  ICMJE 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.
Intervention: Procedure: Pericardiotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
4
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923673
Other Study ID Numbers  ICMJE 18-010106
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barry Borlaug, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry A Borlaug, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP