REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:9/9/2018
Start Date:July 2015
End Date:August 29, 2018

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

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).

Inclusion Criteria:

1. Ambulatory.

2. Chronic systolic heart failure ≥ 12 months.

3. NYHA II - IV for at least 45 of the last 60 days.

4. Last documented left ventricular ejection fraction ≤ 35% by any imaging modality.

5. Age 18 - 80 years.

6. Under the care of a cardiologist at study site.

7. 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.

8. Has ICD or CRT-D. If CRT-D, present for ≥ 3 months.

9. 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

10. 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:

1. 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).

2. Patient is not likely to be compliant with the protocol, in the opinion of the
Investigator.

3. Currently hospitalized.

4. Current use of an intravenous inotrope.

5. Primary functional limitation from non-cardiac diagnosis even if not likely to limit
survival.

6. Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL
at time of enrollment.

7. Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active
myocarditis or congenital heart disease with significant structural abnormality.

8. Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient.

9. 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.

10. Uncorrected hyperthyroidism or hypothyroidism.

11. Pregnancy.
We found this trial at
21
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Rhondalyn McClean, MD
Phone: 610-457-3988
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
Principal Investigator: Shawn Robinson, MD
Phone: 410-328-7623
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Garrick Stewart, MD, MPH
Phone: 617-732-7174
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Ulrich Jorde, MD
Phone: 718-920-8780
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Jeffrey Teuteberg, MD
Phone: 412-692-4828
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Josef Stehlik, MD
Phone: 801-587-9048
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Abington, Pennsylvania 19001
Principal Investigator: Donald Haas, MD
Phone: 215-481-4100
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Abington, PA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Maryse Palardy, MD
Phone: 734-232-4606
University of Michigan The University of Michigan was founded in 1817 as one of the...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Amrut V. Ambardekar, MD
Phone: 303-724-6473
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Stuart Russell, MD
Phone: 410-502-2707
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Beverly Hills, California 90211
Principal Investigator: Michelle Kittleson, MD
Phone: 310-248-7132
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Birmingham, Alabama 35294
Principal Investigator: Salpy Pamboukian, MD, MSPH
Phone: 205-975-8511
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Maria Mountis, DO
Phone: 216-445-1174
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Dallas, Texas 75390
Principal Investigator: Jennifer Thibodeau, MD
Phone: 214-645-8040
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Dallas, TX
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: David Lanfear, MD
Phone: 313-874-3222
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Falls Church, Virginia 22042
Principal Investigator: Palak Shah, MD
Phone: 703-776-3697
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Falls Church, VA
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Jerry Estep, MD
Phone: 713-441-3576
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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New York, New York 10029
Principal Investigator: Anu Lala, MD
Phone: 212-241-7300
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New York, NY
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Oklahoma City, Oklahoma 73112
Principal Investigator: Douglas A. Horstmanshof, MD, FACC
Phone: 405-951-8217
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Oklahoma City, OK
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Keyur Shah, MD
Phone: 804-828-1601
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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