This study will test whether it is safe and practical for patients with severe heart failure who are supported by an Impella 5.5 heart pump to do a special exercise test called a CPET. Patients can walk while on the device, however, formal exercise testing has not been well studied. The study will also look at how patients' oxygen use during exercise changes with the heart pump and whether these results can help identify different patient groups and predict outcomes.
Cardiopulmonary Exercise Testing in Ambulatory Patients with Heart Failure- Cardiogenic Shock Supported by Impella 5.5
Cardiopulmonary Exercise Testing in Ambulatory Patients with Heart Failure- Cardiogenic Shock Supported by Impella 5.5
Cardiogenic shock, Heart failure
All genders
18-75
Recruiting now
Overview
Principal Investigator: Mohammed Imran Aslam, MD
Contact Us
Jamie Rubinstein/Jamie.Rubinstein@tuftsmedicine.org
Study details
Inclusion Criteria
- LVEF of <35% prior to Impella 5.5 implantation. HF-CS defined as CS etiology due to acute-on-chronic decompensated nonischemic or ischemic cardiomyopathy or de novo nonischemic cardiomyopathy
- CS managed with Impella 5.5, with stable position of the device as confirmed by standard transthoracic echocardiography and with no suction alarms
- Documented clearance for ambulation according to evaluation completed by a physical therapist. The subject must additionally demonstrate independent ambulation on the day prior to anticipated CPET
Exclusion Criteria
- Patient is unable to provide consent
- Evidence of ongoing hemodynamic instability or hypoperfusion, including persistently lactic acid elevation or laboratory or clinical evidence of progressive or ongoing end-organ injury
- Severe right ventricular (RV) dysfunction, as adjudicated by clinical, hemodynamic, and echocardiographic findings, that requires treatment with more than one intravenous inotrope and/or a RV t-MCS device.
Study Requirements
This study uses CPET (about 20 minutes on a stationary bike) to measure heart and lung function during exercise. Testing is done in the cardiac catheterization lab with close medical supervision. Nno X-rays; routine CPET blood tests (e.g., lactate, blood gases) are collected. The first CPET occurs 4–8 days after Impella 5.5 placement and is repeated about every 14 days while the device remains in place, unless the patient receives a transplant, long-term device, or recovers enough for removal. A transthoracic echocardiogram will be performed within 3 hours of completion of each CPET to assess for any changes. A six-minute walk test is done the day before the first CPET and daily. Safety is monitored, and clinical outcomes and imaging are recorded.