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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01369407
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : September 7, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Information provided by (Responsible Party):
Keith Aaronson, University of Michigan

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.

Condition or disease Intervention/treatment
Congestive Heart Failure Other: No Intervention

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]
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)
Actual Study Start Date : July 2015
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Enrolled Subjects
Enrolled subjects participate for up to 2 years
Other: No Intervention
Not an interventional study

Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]
  2. 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. [ Time Frame: 2 years ]
  3. 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. [ Time Frame: 2 years. ]
  4. To determine health-associated costs for heart failure subjects in the registry. [ Time Frame: 2 years. ]
  5. 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. [ Time Frame: 2 years. ]

Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 2 years ]
    Assessed throughout participation

  2. Stroke [ Time Frame: 2 years ]
    Assessed throughout participation

  3. MCSD [ Time Frame: 2 years ]
    Assessed throughout participation (study endpoint)

  4. Transplant [ Time Frame: 2 years ]
    Assessed throughout participation (study endpoint)

  5. Death [ Time Frame: 2 years ]
    Assessed throughout participation

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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


    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)


    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01369407

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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Cedars-Sinai Medical Care Foundation
Beverly Hills, California, United States, 90211
United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University, St. Louis
Saint Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Abington Jefferson Health
Abington, Pennsylvania, United States, 19001
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Houston Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
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Principal Investigator: Keith Aaronson, MD, MS University of Michigan
Principal Investigator: Garrick Stewart, MD Brigham and Women's Hospital
Study Chair: Doug Mann, MD University of Washington - St. Louis

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Keith Aaronson, Bertram Pitt M.D. Collegiate Professor of Cardiovascular Medicine and Professor of Internal Medicine, Medical School, University of Michigan Identifier: NCT01369407     History of Changes
HHSN268201100026C ( Other Grant/Funding Number: NHLBI )
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by Keith Aaronson, University of Michigan:
Heart failure
Heart Diseases
Cardiovascular Diseases
Heart Failure NYHA class III
Advanced heart failure
Systolic Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases