Brief Summary
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.
Brief Title
Multiple Cardiac Sensors for the Management of Heart Failure
Detailed Description
Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.
Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.
Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure, Congestive
Eligibility Criteria
Inclusion Criteria:
1. Subject is age 18 or above, or of legal age to give informed consent
2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
4. Remotely monitored by LATITUDE 5.0 (or future versions)
5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
6. Meet at least one of the three following conditions:
* At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
* Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
* N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
Exclusion Criteria:
1. The subject is unable to sign or refuses to sign the patient informed consent
2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
3. The subject is implanted with unipolar right atrial or right ventricular leads
4. Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
5. Subject is pregnant or planning to become pregnant during the study
6. Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)
7. Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
8. Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
9. A life expectancy of less than 12 months per clinician discretion
10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.
1. Subject is age 18 or above, or of legal age to give informed consent
2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
4. Remotely monitored by LATITUDE 5.0 (or future versions)
5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
6. Meet at least one of the three following conditions:
* At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
* Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
* N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
Exclusion Criteria:
1. The subject is unable to sign or refuses to sign the patient informed consent
2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
3. The subject is implanted with unipolar right atrial or right ventricular leads
4. Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
5. Subject is pregnant or planning to become pregnant during the study
6. Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)
7. Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
8. Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
9. A life expectancy of less than 12 months per clinician discretion
10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.
Inclusion Criteria
Inclusion Criteria:
1. Subject is age 18 or above, or of legal age to give informed consent
2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
4. Remotely monitored by LATITUDE 5.0 (or future versions)
5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
6. Meet at least one of the three following conditions:
* At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
* Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
* N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
1. Subject is age 18 or above, or of legal age to give informed consent
2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
4. Remotely monitored by LATITUDE 5.0 (or future versions)
5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
6. Meet at least one of the three following conditions:
* At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
* Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
* N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment
Gender
All
Gender Based
false
Keywords
heart failure
diagnostics
heart sounds
CRT-D
ICD
remote monitoring
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03237858
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
92125179
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Multiple Cardiac Sensors for the Management of Heart Failure
Primary Outcomes
Outcome Description
Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.
Outcome Measure
Manage-HF Phase I
Outcome Time Frame
Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jooyoung Shin
Investigator Email
jushin@montefiore.org
Investigator Phone