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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by University of Michigan
Sponsor:
Collaborators:
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 23, 2015
Last verified: July 2015

June 1, 2011
July 23, 2015
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 (20) 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.
 
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 for ≥ 3 months.
  7. On all 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. Receiving CRT-D therapy for ≥ 3 months.
  9. Has ICD.
  10. Hospitalized (≥ 24 hours) for acute or acute on chronic heart failure:

    1. ≥ 2 times in the past year or
    2. 1 time in the past year and has at least one of the following*: i. Serum sodium ≤ 133 mEq/L (obtained as an outpatient)** ii. Serum BNP ≥ 1000 pg/mL or NT-proBNP ≥ 4000 pg/mL** iii. Heart Failure Survival Score (HFSS) ≤ 7.19*** iv. Seattle Heart Failure Model (SHFM) one year predicted survival ≤ 83%*** v. Peak VO2 ≤ 55% of predicted for age by Wasserman equation or ≤ 14 ml/kg/min, with RER ≥ 1.1*** vi. 6 minute walk test (6MWT) distance ≤ 350 m without significant non-cardiac limitation**

      • 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) ** Obtained within the prior 30 days ***Obtained within the prior 90 days
  11. 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. Clinical characteristics consistent with INTERMACS Patient Profile 1-4.
  3. Intravenous inotrope therapy within the prior 3 months.
  4. Three (3) or more hospitalizations for acute on chronic heart failure in the prior 6 months or any hospitalization for acute on chronic heart failure in the prior 1 month. Note: Admissions for planned procedure (e.g., ICD generator change, implantation of CRT-D) are not an exclusion.
  5. Any comorbidity, non-adherence, drug or alcohol abuse, other psychosocial problem or lack of social support that would likely preclude future VAD therapy or negatively impact registry participation/follow-up. Note: Patients who would not be a VAD candidate for technical issues such as mechanical aortic valve, multiple prior sternotomies, calcified left ventricular apex, intracavitary thrombus, or sternal reentry are not excluded from REVIVAL).
  6. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival.
  7. Chronic hemodialysis or peritoneal dialysis.
  8. Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant structural abnormality.
  9. Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient.
  10. 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.
  11. Uncorrected hyperthyroidism or hypothyroidism.
  12. Pregnancy.
Both
18 Years to 80 Years
No
Contact: Jennifer L Frick, MSA 734-998-7614 frick@umich.edu
Contact: Huwaida B Betts, MBChB, MPH 734-763-0597 huwaidab@umich.edu
United States
 
NCT01369407
REVIVE-IT REGISTRY (REVIVAL), HHSN268201100026C
No
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 2015

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