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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Michigan
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: January 13, 2016
Last verified: January 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
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

Contacts
Contact: Jennifer L Frick, MSA 734-998-7614 frick@umich.edu
Contact: Laurie Rigan 734-998-7435 llacroix@umich.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Gina Horton, RN    205-975-8511    ghorton@uab.edu   
Principal Investigator: Salpy Pamboukian, MD, MSPH         
United States, California
Cedars-Sinai Medical Care Foundation Not yet recruiting
Beverly Hills, California, United States, 90211
Contact: Maria Thottam, BS, CCRP    310-248-7132    maria.thottam@cshs.org   
Principal Investigator: Michelle Kittleson, MD         
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Tammy Nguyen    303-724-6472    tammy.2.nguyen@ucdenver.edu   
Principal Investigator: Amrut V. Ambardekar, MD         
United States, Maryland
University of Maryland, Baltimore Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Jennifer Marshall    410-328-7623    jmarshall1@umaryland.edu   
Principal Investigator: Shawn Robinson, MD         
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Mia Hamm    410-502-2707    Mhamm1@jhmi.edu   
Principal Investigator: Stuart Russell, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Susan Anello, RN.BSN    617-732-7174    manello@partners.org   
Principal Investigator: Garrick Stewart, MD, MPH         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Neha Shah    734-232-4606    neshah@umich.edu   
Principal Investigator: Maryse Palardy, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Ashley Tanis    313-874-3222    atanis1@hfhs.org   
Principal Investigator: David Lanfear, MD         
United States, Missouri
Washington University, St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Donna Whitehead, RN    314-454-7422    DWhitehe@dom.wustl.edu   
Principal Investigator: Gregory Ewald, MD, FACC         
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Johanna Oviedo    718-920-8780    joviedo@montefiore.org   
Principal Investigator: Ulrich Jorde, MD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: John Donehey    212-241-7300    john.donehey@mountsinai.org   
Principal Investigator: Anu Lala, MD         
United States, Ohio
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Linda Kerchenski, RN    216-445-1174    kerchel@ccf.org   
Principal Investigator: Maria Mountis, DO         
United States, Oklahoma
INTEGRIS Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Mandy Williams    405-951-8217    Mandy.WIlliams@integrisok.com   
Principal Investigator: Douglas A. Horstmanshof, MD, FACC         
United States, Pennsylvania
Abington Jefferson Health Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Therese Prentice, CRPN    215-481-4100    TPrentice@abingtonhealth.org   
Principal Investigator: Donald Haas, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Laura Fleszar    610-457-3988    Laura.Fleszar@uphs.upenn.edu   
Principal Investigator: Rhondalyn McClean, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Traci McGaha    412-692-4828    mcgahatl4@upmc.edu   
Principal Investigator: Jeffrey Teuteberg, MD         
United States, Texas
UT Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Lynn Fernandez    214-645-8040    Lynn.Fernandez@UTSouthwestern.edu   
Principal Investigator: Jennifer Thibodeau, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Colleen Brown, BS,CCRC    713-441-3576    cbrown4@houstonmethodist.org   
Principal Investigator: Jerry Estep, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jeff Gibbs    801-587-9048    jeffrey.gibbs@hsc.utah.edu   
Principal Investigator: Josef Stehlik, MD         
United States, Virginia
Inova Heart and Vascular Institute Recruiting
Falls Church, Virginia, United States, 22042
Contact: Vinita Gupta    703-776-3697    vinita.gupta@inova.org   
Principal Investigator: Palak Shah, MD         
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Melissa Sears, RN    804-828-1601    melissa.sears@vcuhealth.org   
Principal Investigator: Keyur Shah, MD         
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

No publications provided

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: January 13, 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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on February 11, 2016