NCT01369407

REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
OTHER	No Intervention	Not an interventional study

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-08-29
• Completion: 2018-08-29
• First posted: 2011-06-08
• Last updated: 2018-09-07

Locations

21 sites across 1 country: United States