REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

Completed

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT01369407

Run by

University of Michigan

People needed

400

Starts

2015-07-01

Expected to finish

2018-08-29

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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
• 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.
• Written Informed consent given.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.