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.
Brief Title
REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE
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).
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Congestive Heart Failure
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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Heart failure
HF
Heart Diseases
Cardiovascular Diseases
Heart Failure NYHA class III
Advanced heart failure
Systolic Heart Failure
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT01369407
Org Class
Other
Org Full Name
University of Michigan
Org Study Id
REVIVE-IT REGISTRY (REVIVAL)
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)
Primary Outcomes
Outcome Measure
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
Outcome Time Frame
2 years
Outcome Measure
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.
Outcome Time Frame
2 years
Outcome Measure
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.
Outcome Time Frame
2 years.
Outcome Measure
To determine health-associated costs for heart failure subjects in the registry.
Outcome Time Frame
2 years.
Outcome Measure
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.
Outcome Time Frame
2 years.
Secondary Ids
Secondary Id
HHSN268201100026C
Secondary Outcomes
Outcome Description
Assessed throughout participation
Outcome Time Frame
2 years
Outcome Measure
Hospitalization
Outcome Description
Assessed throughout participation
Outcome Time Frame
2 years
Outcome Measure
Stroke
Outcome Description
Assessed throughout participation (study endpoint)
Outcome Time Frame
2 years
Outcome Measure
MCSD
Outcome Description
Assessed throughout participation (study endpoint)
Outcome Time Frame
2 years
Outcome Measure
Transplant
Outcome Description
Assessed throughout participation
Outcome Time Frame
2 years
Outcome Measure
Death
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ulrich Jorde
Investigator Email
ujorde@montefiore.org
Investigator Phone
Categories Mesh Debug
Heart/Cardiovascular --- HEART FAILURE
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
HEART FAILURE
HEART DISEASES
CARDIOVASCULAR DISEASES
HEART FAILURE, SYSTOLIC