REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

NCT01369407 | Completed

• 2 other identifiers: REVIVE-IT REGISTRY (REVIVAL)HHSN268201100026C
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 21

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.

Conditions

Congestive Heart Failure

Keywords

Heart failure; HF; Heart Diseases; Cardiovascular Diseases; Heart Failure NYHA class III; Advanced heart failure; Systolic Heart Failure

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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.

• To determine health-associated costs for heart failure subjects in the registry.

  2 years.

• 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 Outcomes (5)

• Hospitalization

  2 years

• Stroke

  2 years

• MCSD

  2 years

• Transplant

  2 years

• Death

  2 years

Study Arms (1)

Enrolled Subjects

Enrolled subjects participate for up to 2 years

Other: No Intervention

Interventions

No Intervention OTHER

Not an interventional study

Enrolled Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ambulatory.
• Chronic systolic heart failure ≥ 12 months.
• NYHA II - IV for at least 45 of the last 60 days.
• Last documented left ventricular ejection fraction ≤ 35% by any imaging modality.
• Age 18 - 80 years.
• Under the care of a cardiologist at study site.
• 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.
• Has ICD or CRT-D. If CRT-D, present for ≥ 3 months.
• 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
• 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)
• 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

You may not qualify if:

• 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).
• Patient is not likely to be compliant with the protocol, in the opinion of the Investigator.
• Currently hospitalized.
• Current use of an intravenous inotrope.
• Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival.
• Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL at time of enrollment.
• Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant structural abnormality.
• Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient.
• 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.
• Uncorrected hyperthyroidism or hypothyroidism.
• Pregnancy.

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (21)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Care Foundation

Beverly Hills, California, 90211, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63110, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

INTEGRIS

Oklahoma City, Oklahoma, 73112, United States

Location

Abington Jefferson Health

Abington, Pennsylvania, 19001, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

• 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.

  PMID: 38970587 DERIVED

• 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.

  PMID: 36259388 DERIVED

• 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.

  PMID: 33549559 DERIVED

• 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.

  PMID: 32418478 DERIVED

• 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.

  PMID: 27836022 DERIVED

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.

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases; Heart Failure, Systolic

Study Officials

• Keith Aaronson, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Garrick Stewart, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Doug Mann, MD

  University of Washington - St. Louis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bertram Pitt M.D. Collegiate Professor of Cardiovascular Medicine and Professor of Internal Medicine, Medical School

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 8, 2011
• Study Start: July 1, 2015
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (21)