REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

NCT ID: NCT01369407

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-08-29

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.

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).

Conditions

Congestive Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Enrolled Subjects

Enrolled subjects participate for up to 2 years

No Intervention

Intervention Type: OTHER

Not an interventional study

Interventions

No Intervention

Not an interventional study

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Keith Aaronson

Bertram Pitt M.D. Collegiate Professor of Cardiovascular Medicine and Professor of Internal Medicine, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith Aaronson, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Garrick Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Doug Mann, MD

Role: STUDY_CHAIR

University of Washington - St. Louis

Locations

University of Alabama

Birmingham, Alabama, United States

Cedars-Sinai Medical Care Foundation

Beverly Hills, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University, St. Louis

St Louis, Missouri, United States

Mount Sinai Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

INTEGRIS

Oklahoma City, Oklahoma, United States

Abington Jefferson Health

Abington, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

UT Southwestern

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Inova Heart and Vascular Institute

Falls Church, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Aaronson KD, Stewart GC, Stevenson LW, Richards B, Khalatbari S, Cascino TC, Ambardekar AV, Stehlik J, Lala A, Kittleson MM, Palardy M, Mountis MM, Pagani FD, Jeffries N, Taddei-Peters WC, Mann DL; REVIVAL Investigators. Optimizing Triage of Ambulatory Patients With Advanced Heart Failure: 2-Year Outcomes From REVIVAL. JACC Heart Fail. 2024 Oct;12(10):1734-1746. doi: 10.1016/j.jchf.2024.05.008. Epub 2024 Jul 3.

Reference Type: DERIVED

PMID: 38970587 (View on PubMed)

Cascino TM, Colvin MM, Lanfear DE, Richards B, Khalatbari S, Mann DL, Taddei-Peters WC, Jeffries N, Watkins DC, Stewart GC, Aaronson KD; REVIVAL Investigators. Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study. Circ Heart Fail. 2023 Jan;16(1):e009745. doi: 10.1161/CIRCHEARTFAILURE.122.009745. Epub 2022 Oct 19.

Reference Type: DERIVED

PMID: 36259388 (View on PubMed)

Lala A, Shah KB, Lanfear DE, Thibodeau JT, Palardy M, Ambardekar AV, McNamara DM, Taddei-Peters WC, Baldwin JT, Jeffries N, Khalatbari S, Spino C, Richards B, Mann DL, Stewart GC, Aaronson KD, Mancini DM; REVIVAL Investigators. Predictive Value of Cardiopulmonary Exercise Testing Parameters in Ambulatory Advanced Heart Failure. JACC Heart Fail. 2021 Mar;9(3):226-236. doi: 10.1016/j.jchf.2020.11.008. Epub 2021 Feb 3.

Reference Type: DERIVED

PMID: 33549559 (View on PubMed)

Cascino TM, Kittleson MM, Lala A, Stehlik J, Palardy M, Pamboukian SV, Ewald GA, Mountis MM, Horstmanshof DA, Robinson SW, Shah P, Jorde UP, McLean RC, Richards B, Khalatbari S, Spino C, Taddei-Peters WC, Grady KL, Mann DL, Stevenson LW, Stewart GC, Aaronson KD; REVIVAL Investigators. Comorbid Conditions and Health-Related Quality of Life in Ambulatory Heart Failure Patients: REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life REVIVAL). Circ Heart Fail. 2020 May;13(5):e006858. doi: 10.1161/CIRCHEARTFAILURE.119.006858. Epub 2020 May 18.

Reference Type: DERIVED

PMID: 32418478 (View on PubMed)

Pagani FD, Aaronson KD, Kormos R, Mann DL, Spino C, Jeffries N, Taddei-Peters WC, Mancini DM, McNamara DM, Grady KL, Gorcsan J 3rd, Petrucci R, Anderson AS, Glick HA, Acker MA, Eduardo Rame J, Goldstein DJ, Pamboukian SV, Miller MA, Timothy Baldwin J; REVIVE-IT Investigators. The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy. J Heart Lung Transplant. 2016 Nov;35(11):1277-1283. doi: 10.1016/j.healun.2016.09.002. Epub 2016 Oct 6.

Reference Type: DERIVED

PMID: 27836022 (View on PubMed)

Other Identifiers

HHSN268201100026C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REVIVE-IT REGISTRY (REVIVAL)

Identifier Type: -

Identifier Source: org_study_id