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

June 1, 2011
July 7, 2016
July 2015
June 2018   (final data collection date for primary outcome measure)
  • 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 ]
Composite outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  1. Survival
  2. Freedom from major disabling stroke (defined as Modified Rankin Scale (MRS) > 4)
  3. Improvement of 6 Minute Walk Test distance by >75 meters from pre-randomization baseline
Complete list of historical versions of study NCT01369407 on ClinicalTrials.gov Archive Site
  • 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
  • Primary composite outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1. Survival
    2. Freedom from major disabling stroke (defined as Modified Rankin Scale (MRS) > 4)
    3. Improvement of 6 Minute Walk Test distance by >75 meters from pre-randomization baseline
  • Functional capacity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by: 6 Minute Walk test, peak oxygen consumption, % predicted V02, lean body mass adjusted peak Vo2, VE/VCO2 slope, anaerobic threshold, NYHA functional class
  • Health-related Quality of Life and Health Utility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Assessed by completion of various instruments
  • Neurocognition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Heart failure-related adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Worsening heart failure resulting in non-elective hospitalization, emergency department visit, urgent clinic visit at which intravenous therapy is administered.
  • Hospital Readmission [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cost and cost-effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • LVAD associated adverse events (as defined by INTERMACS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cross-over rates to LVAD in the OMM arm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cross-over rates to cardiac transplantation in the OMM and LVAD arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE
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).

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Retention:   Samples With DNA
Description:
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.
Non-Probability Sample
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.
Congestive Heart Failure
Other: No Intervention
Not an interventional study
Enrolled Subjects
Enrolled subjects participate for up to 2 years
Intervention: Other: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
June 2019
June 2018   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369407
REVIVE-IT REGISTRY (REVIVAL), HHSN268201100026C
No
Not Provided
Not Provided
Keith Aaronson, University of Michigan
University of Michigan
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Brigham and Women's Hospital
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
University of Michigan
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP