REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE (REVIVAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Information provided by (Responsible Party):
Keith Aaronson, University of Michigan
ClinicalTrials.gov Identifier:
NCT01369407
First received: June 1, 2011
Last updated: July 7, 2016
Last verified: July 2016
  Purpose
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 Intervention
Congestive Heart Failure
Other: No Intervention

Study Type: Observational [Patient Registry]
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • To determine health-associated costs for heart failure subjects in the registry. [ Time Frame: 2 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed throughout participation

  • Stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed throughout participation

  • MCSD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed throughout participation (study endpoint)

  • Transplant [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed throughout participation (study endpoint)

  • Death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 400
Study Start Date: July 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Enrolled Subjects
Enrolled subjects participate for up to 2 years
Other: No Intervention
Not an interventional study

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369407

Locations
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
St. 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
INTEGRIS
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
Investigators
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
  More Information

Responsible Party: Keith Aaronson, Bertram Pitt M.D. Collegiate Professor of Cardiovascular Medicine and Professor of Internal Medicine, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT01369407     History of Changes
Other Study ID Numbers: REVIVE-IT REGISTRY (REVIVAL)  HHSN268201100026C 
Study First Received: June 1, 2011
Last Updated: July 7, 2016
Health Authority: United States: Observational Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Michigan:
Heart failure
HF
Heart Diseases
Cardiovascular Diseases
Heart Failure NYHA class III
Advanced heart failure
Systolic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 27, 2016