REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis.
REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis. Within the broader goal of 1) improving prognostic assessment in chronic, ambulatory, advanced systolic heart failure, additional targeted goals are to 2) better inform the selection of appropriate candidates for a future study of a strategy of early LVAD therapy vs. optimal medical management in this population, and 3) determine the feasibility of identifying candidates for such a trial. Therefore, the target population will have known high-risk features for increased mortality and hospitalization (e.g., frequent hospitalization, reduced exercise capacity, elevated BNP or N-terminal proBNP, increased Seattle Heart Failure Model risk score, reduced Heart Failure Survival Score). The REVIVE-IT Registry (i.e., REVIVAL) is a prospective cohort study to be conducted in up to twenty five (25) participating Clinical Sites in the USA. The study will continue until up to 400 eligible heart failure heart failure subjects have been enrolled (estimated length of accrual is 12 months).
Study Type
OBSERVATIONAL
Enrollment
400
Not an interventional study
University of Alabama
Birmingham, Alabama, United States
To characterize clinical outcomes, quality of life and functional impairment over two (2) years in a population of ambulatory patients on evidence-based therapy with advanced chronic systolic heart failure who may benefit from VAD therapy
Time frame: 2 years
To evaluate the relationship between heart failure subject's modeled prognosis, self assessed prognosis, preferences for end of life care and thresholds for considering VAD implant.
Time frame: 2 years
To evaluate caregiver burden associated with heart failure subject's measures of heart failure severity, quality of life, functional limitations and with preferences for care and thresholds for considering device implant.
Time frame: 2 years.
To determine health-associated costs for heart failure subjects in the registry.
Time frame: 2 years.
To provide the REVIVE-IT Registry to the INTERMACS study group to be used in comparative analyses of outcomes of patients treated with medical versus VAD therapy.
Time frame: 2 years.
Hospitalization
Assessed throughout participation
Time frame: 2 years
Stroke
Assessed throughout participation
Time frame: 2 years
MCSD
Assessed throughout participation (study endpoint)
Time frame: 2 years
Transplant
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Cedars-Sinai Medical Care Foundation
Beverly Hills, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University, St. Louis
St Louis, Missouri, United States
Mount Sinai Hospital
New York, New York, United States
...and 11 more locations
Assessed throughout participation (study endpoint)
Time frame: 2 years
Death
Assessed throughout participation
Time frame: 2 years