REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE (REVIVAL)
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| ClinicalTrials.gov Identifier: NCT01369407 |
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Recruitment Status :
Completed
First Posted : June 8, 2011
Last Update Posted : September 7, 2018
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| Tracking Information | ||||||||||
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| First Submitted Date | June 1, 2011 | |||||||||
| First Posted Date | June 8, 2011 | |||||||||
| Last Update Posted Date | September 7, 2018 | |||||||||
| Actual Study Start Date | July 2015 | |||||||||
| Actual Primary Completion Date | August 29, 2018 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
Composite outcome [ Time Frame: 2 years ]
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE | |||||||||
| Official Title | REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life) | |||||||||
| Brief 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). |
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| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Years | |||||||||
| Biospecimen | Retention: Samples With DNA Description: Biomarker Samples will be collected at the Baseline B assessment. Samples for Genomic Analysis will be collected at the Baseline B visit for subjects that consented to collection of this sample type.
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| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Medical records should be reviewed to assess for potential enrollment into the REVIVE-IT Registry. Heart failure subjects that meet all criteria should be approached to consent for this study. | |||||||||
| Condition | Congestive Heart Failure | |||||||||
| Intervention | Other: No Intervention
Not an interventional study
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| Study Groups/Cohorts | Enrolled Subjects
Enrolled subjects participate for up to 2 years
Intervention: Other: No Intervention
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
400 | |||||||||
| Original Estimated Enrollment |
100 | |||||||||
| Actual Study Completion Date | August 29, 2018 | |||||||||
| Actual Primary Completion Date | August 29, 2018 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
12. Written Informed consent given. Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01369407 | |||||||||
| Other Study ID Numbers | REVIVE-IT REGISTRY (REVIVAL) HHSN268201100026C ( Other Grant/Funding Number: NHLBI ) |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | Keith Aaronson, University of Michigan | |||||||||
| Original Responsible Party | Francis Pagani, MD, PhD, University of Mighigan | |||||||||
| Current Study Sponsor | University of Michigan | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | University of Michigan | |||||||||
| Verification Date | September 2018 | |||||||||