Pericardial Resection to Treat Heart Failure

NCT03073668 | Completed

• 1 other identifier: 17-000261
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, approximately 1 hour

Secondary Outcomes (2)

• Change in Pulmonary Artery Pressure (PAP)

  Baseline, approximately 1 hour

• Change in Right Arterial Pressure (RAP)

  Baseline, approximately 1 hour

Study Arms (1)

Heart Failure Patients

EXPERIMENTAL

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.

Procedure: Anterior pericardiotomy; Drug: Saline

Interventions

Anterior pericardiotomy PROCEDURE

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.

Heart Failure Patients

Saline DRUG

During the measurement of cardiac hemodynamic tests, a saline bolus of 300 ml will be administered over 1-2 minutes.

Heart Failure Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Barry A Borlaug

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, College of Medicine

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: March 20, 2017
• Primary Completion: January 23, 2018
• Study Completion: February 2, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)