Clincosm LogoSign in Get a demo

REVIVAL: REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01369407
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Brigham and Women's Hospital (Other)
400
Enrollment
21
Locations
37.9
Actual Duration (Months)
19
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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).

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Aug 29, 2018
Actual Study Completion Date :
Aug 29, 2018

Arms and Interventions

Arm Intervention/Treatment
Enrolled Subjects

Enrolled subjects participate for up to 2 years

Other: No Intervention
Not an interventional study

Outcome Measures

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 [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. [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. [2 years.]

  4. To determine health-associated costs for heart failure subjects in the registry. [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. [2 years.]

Secondary Outcome Measures

  1. Hospitalization [2 years]

    Assessed throughout participation

  2. Stroke [2 years]

    Assessed throughout participation

  3. MCSD [2 years]

    Assessed throughout participation (study endpoint)

  4. Transplant [2 years]

    Assessed throughout participation (study endpoint)

  5. Death [2 years]

    Assessed throughout participation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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*:

  1. 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:

  1. 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

  1. 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.

  2. 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

Locations

Site City State Country Postal Code
1 University of Alabama Birmingham Alabama United States 35294
2 Cedars-Sinai Medical Care Foundation Beverly Hills California United States 90211
3 University of Colorado, Denver Aurora Colorado United States 80045
4 University of Maryland, Baltimore Baltimore Maryland United States 21201
5 Johns Hopkins Hospital Baltimore Maryland United States 21287
6 Brigham and Women's Hospital Boston Massachusetts United States 02115
7 University of Michigan Ann Arbor Michigan United States 48109
8 Henry Ford Hospital Detroit Michigan United States 48202
9 Washington University, St. Louis Saint Louis Missouri United States 63110
10 Montefiore Medical Center Bronx New York United States 10467
11 Mount Sinai Hospital New York New York United States 10029
12 Cleveland Clinic Foundation Cleveland Ohio United States 44195
13 INTEGRIS Oklahoma City Oklahoma United States 73112
14 Abington Jefferson Health Abington Pennsylvania United States 19001
15 University of Pennsylvania Philadelphia Pennsylvania United States 19104
16 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
17 UT Southwestern Dallas Texas United States 75390
18 Houston Methodist Hospital Houston Texas United States 77030
19 University of Utah Salt Lake City Utah United States 84132
20 Inova Heart and Vascular Institute Falls Church Virginia United States 22042
21 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
Other Study ID Numbers:
  • REVIVE-IT REGISTRY (REVIVAL)
  • HHSN268201100026C
First Posted:
Jun 8, 2011
Last Update Posted:
Sep 7, 2018
Last Verified:
Sep 1, 2018
Keywords provided by Keith Aaronson, Bertram Pitt M.D. Collegiate Professor of Cardiovascular Medicine and Professor of Internal Medicine, Medical School, 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

Study Results

No Results Posted as of Sep 7, 2018