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Pericardial Resection to Treat Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior pericardiotomy
Saline
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion

  • >17 years old
  • Subjects having open sternotomy for either aortic valve stenosis or coronary artery bypass grafting (or both)
  • Provide informed consent Exclusion
  • <18 years old

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Failure Patients

Arm Description

After obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. The chest will be open but pericardium left intact. Cardiac hemodynamics will be measured using PA catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes). The surgical team will perform anterior pericardiotomy. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure. The surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact.

Outcomes

Primary Outcome Measures

Change in Pulmonary Artery Wedge Pressure (PAWP)
Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

Secondary Outcome Measures

Change in Pulmonary Artery Pressure (PAP)
Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.
Change in Right Arterial Pressure (RAP)
Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.

Full Information

First Posted
March 3, 2017
Last Updated
May 11, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03073668
Brief Title
Pericardial Resection to Treat Heart Failure
Official Title
The Effects of Pericardiotomy on Diastolic Reserve in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
February 2, 2019 (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
The researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. The researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.
Detailed Description
This study will enroll patients with risk factors for LV diastolic dysfunction, either coronary artery disease or aortic stenosis, who are already undergoing cardiac surgery for clinical purposes (e.g. coronary artery bypass grafting or valvular heart disease). Hemodynamic tests will be performed using standard clinical resources used as part of routine care in this setting, including pulmonary artery (PA) catheterization. After obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. The chest will be open but pericardium left intact. Cardiac hemodynamics (PA wedge pressure, PAWP; PA pressure, PAP, right atrial pressure, RAP) will be measured using PA catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes). The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint similar to our percutaneous approach but using currently-available surgical tools. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure (standard care). The surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact. Our hypothesis is that as compared to pericardium intact, the increase in PAWP with volume loading will be reduced following opening of the pericardium.

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
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Patients
Arm Type
Experimental
Arm Description
After obtaining written informed consent, patients will undergo induction with general anesthesia as per clinical practice. The chest will be open but pericardium left intact. Cardiac hemodynamics will be measured using PA catheter already in place at rest, and then during conditions of increased cardiac preload, induced by passive leg elevation and saline bolus (300 ml administered over 1-2 minutes). The surgical team will perform anterior pericardiotomy. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure. The surgical team will then repeat hemodynamic assessments at rest and with acute volume loading (leg raise + saline) in exactly the same manner as with the pericardium intact.
Intervention Type
Procedure
Intervention Name(s)
Anterior pericardiotomy
Intervention Description
The surgical team will perform anterior pericardiotomy. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
During the measurement of cardiac hemodynamic tests, a saline bolus of 300 ml will be administered over 1-2 minutes.
Primary Outcome Measure Information:
Title
Change in Pulmonary Artery Wedge Pressure (PAWP)
Description
Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.
Time Frame
Baseline, approximately 1 hour
Secondary Outcome Measure Information:
Title
Change in Pulmonary Artery Pressure (PAP)
Description
Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.
Time Frame
Baseline, approximately 1 hour
Title
Change in Right Arterial Pressure (RAP)
Description
Patients will undergo induction with general anesthesia, and at baseline the chest will be open, but pericardium left intact. Cardiac hemodynamics will be measured using the Pulmonary Artery Catheter already in place. The surgical team will then perform anterior pericardiotomy, with removal of pericardial restraint, and cardiac hemodynamics will be measured again.
Time Frame
Baseline, approximately 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion >17 years old Subjects having open sternotomy for either aortic valve stenosis or coronary artery bypass grafting (or both) Provide informed consent Exclusion <18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry A Borlaug
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

Pericardial Resection to Treat Heart Failure

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