REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

Completed

• Conditions: Congestive Heart Failure
• Interventions: Other: No Intervention

• Registration Number: NCT01369407
• Lead Sponsor: University of Michigan

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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Study Start: 2015-07
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

11. Written Informed consent given.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled Subjects	No Intervention	Enrolled subjects participate for up to 2 years

Primary Outcome Measures

Name	Time	Method
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 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.
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 determine health-associated costs for heart failure subjects in the registry.	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.

Secondary Outcome Measures

Name	Time	Method
Transplant	2 years	Assessed throughout participation (study endpoint)
Hospitalization	2 years	Assessed throughout participation
Stroke	2 years	Assessed throughout participation
MCSD	2 years	Assessed throughout participation (study endpoint)
Death	2 years	Assessed throughout participation

Trial Locations

Locations (21)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Inova Heart and Vascular Institute; 🇺🇸 Falls Church, Virginia, United States

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

UT Southwestern; 🇺🇸 Dallas, Texas, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Cedars-Sinai Medical Care Foundation; 🇺🇸 Beverly Hills, California, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

INTEGRIS; 🇺🇸 Oklahoma City, Oklahoma, United States

Abington Jefferson Health; 🇺🇸 Abington, Pennsylvania, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Washington University, St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States