REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory. Chronic systolic heart failure ≥ 12 months. NYHA II - IV for at least 45 of the last 60 days. Last documented left ventricular ejection fraction ≤ 35% by any imaging modality. Age 18 - 80 years. Under the care of a cardiologist at study site. On appropriate evidenced -based heart failure medications - ACE inhibitor, ARB or sacubitril/valsartan [LCZ-696]; beta blocker; aldosterone antagonist; hydralazine/long-acting nitrate [required of African-American subjects only] for ≥ 3 months absent contraindications or intolerances. Has ICD or CRT-D. If CRT-D, present for ≥ 3 months. Demonstrated advanced heart failure, including any one of the following*: i. Serum sodium ≤ 135 mEq/L (obtained as an outpatient)** ii. Serum BNP ≥ 750 pg/mL or NT-proBNP ≥ 3000 pg/mL** (obtained as an outpatient) iii. Seattle Heart Failure Model (SHFM) one year predicted survival ≤ 85%** iv. Heart Failure Survival Score (HFSS) ≤ 7.19** v. Peak VO2 ≤ 55% of predicted for age by Wasserman equation or ≤ 14 ml/kg/min, with RER ≥ 1.05*** vi. VE/VC02 slope > 40*** vii. 6 minute walk test (6MWT) distance ≤ 350 m without significant non-cardiac limitation** viii. Currently listed as Heart Transplant Status II due to heart failure limitation Or History of one (1) hospitalization (≥ 24 hours) for acute or acute on chronic heart failure in the past year with additional history to include: i. Serum BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL** (obtained as an outpatient) Or History of two (2) hospitalizations (≥ 24 hours) for acute or acute on chronic heart failure in the past year. * Qualifying measure must be the most recent of that type of measure obtained (i.e., a BNP ≥ 1000 obtained 2 months prior would not qualify the heart failure subject if a more recent BNP was < 1000) **Using values obtained within the prior 90 days, except for peak VO2 within 365 days ***Obtained within the prior 365 days Willingness to continue to receive heart failure care from the enrolling advanced heart failure clinic over the next two (2) years and to come for all scheduled study visits. 12. Written Informed consent given. Exclusion Criteria: 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). Patient is not likely to be compliant with the protocol, in the opinion of the Investigator. Currently hospitalized. Current use of an intravenous inotrope. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival. Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL at time of enrollment. Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant structural abnormality. Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient. Cardiac conditions that are amenable to surgical or percutaneous procedures (other than VAD or transplant) that would substantially improve prognosis and for which this subject is a reasonable candidate, regardless of whether the procedure will or will not be performed. Uncorrected hyperthyroidism or hypothyroidism. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled Subjects<br>Enrolled subjects participate for up to 2 years | Other: No Intervention<br>* Not an interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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. |  | 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. |  | 2 years. | 
| To determine health-associated costs for heart failure subjects in the registry. |  | 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. |  | 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Assessed throughout participation | 2 years | 
| Stroke | Assessed throughout participation | 2 years | 
| MCSD | Assessed throughout participation (study endpoint) | 2 years | 
| Transplant | Assessed throughout participation (study endpoint) | 2 years | 
| Death | Assessed throughout participation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HF, Heart failure, Heart Diseases, Cardiovascular Diseases, Heart Failure NYHA class III, Advanced heart failure, Systolic Heart Failure