Impella Reverse Remodeling in End-Stage Heart Failure

Columbia University

Status: Enrolling

Conditions: Cardiomyopathy; Heart Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06800716

AAAV1201

Details and patient eligibility

About

This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center.

Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study.

Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.

Full description

Percutaneous endovascular mechanical circulatory support (MCS) devices have been increasingly utilized in patients on the waitlist for heart transplantation in the new heart allocation system. However, the number of patients recovering from heart failure and delisted from cardiac transplantation has declined in the new heart allocation system. While significant research has been performed on myocardial recovery with durable left ventricular assist device (LVAD) support, natural course and mechanistic basis of reverse remodeling on percutaneous endovascular MCS remains unknown. The primary objective of this prospective, observational, single-center study is to evaluate whether mechanical circulatory support with Impella 5.5 LVAD in decompensated patients on the waitlist for heart transplantation results in left ventricular reverse remodeling and improvement in end-organ function within 14 days of initiating support. Phenotypic data including clinical information, echocardiography, and hemodynamics will be serially obtained in participants before and after Impella 5.5 LVAD placement. Paired serum samples (pre- and post- Impella support) will be obtained for proteomic analysis. Cardiac tissue samples will be collected at the time of cardiac transplantation for histopathological analysis as well as RNA-sequencing. Candidate genes and proteins of reverse remodeling will be validated using quantitative polymerase chain reaction (qPCR) and Western Blotting. This study will definitively establish the natural course of reverse remodeling in patients with chronically failing ventricles on Impella 5.5 support and determine molecular signals and novel biomarkers of myocardial recovery in this growing population. Data obtained from this study will help determine which patients should pursue recovery pathway as opposed to transplant.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Dilated cardiomyopathy (LVEDD > 5.5 cm and LVEF <25%)
• Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion

Exclusion criteria

• Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
• Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
• Congenital heart disease
• Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
• Evidence of acute myocarditis by endomyocardial biopsy
• Prior heart transplantation
• Mechanical aortic / mitral valve
• Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
• Left Ventricular thrombus
• Left Ventricular rupture
• Cardiac tamponade
• Presence of an Atrial or Ventricular Septal Defect
• Severe right ventricular (RV) Failure requiring mechanical RV support
• Severe peripheral vascular disease precluding placement of the Impella System
• Recent stroke resulting in significant neurological deficit
• Hypercoagulable disease precluding device implantation
• Severe thrombocytopenia (<50,000)
• Contraindication to anticoagulation
• Suspected or known pregnancy or lactating women
• Subject belongs to a vulnerable population

Trial design

50 participants in 1 patient group

Decompensated patients on the waitlist for heart transplantation

Description:

Study participants will receive Impella 5.5 LVAD for treatment of cardiogenic shock and transplant listing as standard of care. Clinical data and serum laboratory including blood counts, end-organ function, nutritional parameters will be collected prospectively from medical records. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.