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Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL-BioLINCC)

Data Access NOTE: Please refer to the "Authorized Access" section below for information about how access to the data from this accession differs from many other dbGaP accessions.

Objectives

To provide a greater understanding of the clinical trajectory of ambulatory patients with chronic, advanced, systolic heart failure that may benefit from ventricular assisted device (VAD) therapy and determine the relationship between baseline clinical measures and prognosis.

Background

Identification of patients at high risk for mortality is vital to advance cardiac therapies. Heart failure scores based on results from earlier clinical trials have generally underestimated mortality in advanced heart failure. Breakthroughs in mechanical circulatory support (MCS) have extended survival and quality of life measures in the most advanced heart failure patients. Increased survival of advanced heart failure patients combined with shortages of donor organs resulted in the United Network to Organ Sharing (UNOS) limiting priority to hospitalized patients or those on MCS. Consequently, those patients who were "less sick" were de-prioritized for transplantation, which resulted in a need to decrease mortality and morbidity through other therapies. There was limited evidence on the clinical characteristics of patients that would benefit the most from MCS compared to new medical therapies such as Left-ventricular assisted device (LVAD). The REVIVAL study was initiated with the broader goal of improving prognostic assessment in chronic, ambulatory, advanced systolic heart failure and to better inform the selection of appropriate candidates for future studies on additional strategies.

Participants

REVIVAL enrolled 400 subjects from participating study sites.

Selected subjects were aged 18-80 and diagnosed with ambulatory chronic systolic heart failure for more than 12 months. They were under the care of a cardiologist at selected study sites on appropriate evidenced -based heart failure medications and willing to continue to receive care from the enrolling advanced heart failure clinic over 2 years. Additional criteria included: NYHA class II -IV for at least 45 of the last 60 days; documented left ventricular ejection fraction ≤ 35% by any imaging modality; ICD or CRT-D.

Subjects were excluded for the following reasons: a known serious medical problem other than heart failure that would be expected to limit 2-year survival (≥50% mortality within 2 years from non-heart failure diagnosis); current hospitalization, current use of an intravenous inotrope; uncorrected thyroid disorder; pregnancy. Subjects were excluded for additional medical or diagnostic criteria that would affect participation in the study.

Design

The REVIVAL registry was a prospective, observational, multicenter patient cohort derived from 25 US clinical sites. Medical records were reviewed to assess for potential enrollment into the study. Heart failure subjects that meet all eligibility criteria were approached to consent for this study. Consented patients participated in the following clinic visits over the course of 2 years: Baseline A, Baseline B and follow up visits at 6,12,18 and 24 months. All study visits were conducted in person.

The following assessments were conducted at all visits: 6-minute walk test, bloodwork, concomitant medications, directed history and physical exams (including NYHA and INTERMACS profiles), gait speed test, handgrip strength test, and Quality of Life (QOL) and health utility questionnaires. A patient diary was distributed at the Baseline A visit.

Additional assessments included: biomarker and genetic testing (Baseline B); caregiver questionnaire (all visits except Baseline A); demographics (Baseline A); ECG (Baseline A, Baseline B, and 12-month visit); Heart Failure Survival Score (Baseline B); maximal treadmill CPX test (Baseline B); Seattle Heart Failure Model Score (Baseline A, Baseline B, and 12-month visit); transthoracic Echo (Baseline B); outcome assessments (all visits except Baseline A).