Clinical trial NCT03073668: Pericardial Resection to Treat Heart Failure
Official title: The Effects of Pericardiotomy on Diastolic Reserve in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pulmonary Artery Wedge Pressure (PAWP)
timeFrame: Baseline, approximately 1 hour
Secondary outcomes:
measure: Change in Pulmonary Artery Pressure (PAP)
timeFrame: Baseline, approximately 1 hour
measure: Change in Right Arterial Pressure (RAP)
timeFrame: Baseline, approximately 1 hour
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry A Borlaug
role: PRINCIPAL_INVESTIGATOR
References: