Multiple Cardiac Sensors for the Management of Heart Failure
NCT ID: NCT03237858
Last Updated: 2024-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-08-30
2020-07-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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HeartLogic ON
ICD and CRT-D devices with HeartLogic alerts turned ON
HeartLogic ON
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
HeartLogic OFF
ICD and CRT-D devices with HeartLogic alerts turned OFF
HeartLogic OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Interventions
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HeartLogic ON
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
HeartLogic OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States
University of Southern California Hospital
Los Angeles, California, United States
Cardiovascular Consultants
Oakland, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Emory University Hospital
Atlanta, Georgia, United States
Parkview Hospital, Inc.
Fort Wayne, Indiana, United States
Community Health Network
Indianapolis, Indiana, United States
Advanced Cardiovascular Specialists
Shreveport, Louisiana, United States
Centra Care Heart and Vascular Center
Cold Spring, Minnesota, United States
United Heart and Vascular
Saint Paul, Minnesota, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Rex Hospital
Raleigh, North Carolina, United States
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
PeaceHealth Sacred Heart Medical Center
Springfield, Oregon, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Stern Cardiovascular
Germantown, Tennessee, United States
Southeast Texas Clinical Research Center
Beaumont, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
L'Hôpital privé du Confluent
Nantes, , France
CHU Pontchaillou
Rennes, , France
Universitätsklinikum Würzburg AöR
Würzburg, , Germany
Countries
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References
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Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.
Heggermont WA, Van Bockstal K. HeartlogicTM: ready for prime time? Expert Rev Med Devices. 2022 Feb;19(2):107-111. doi: 10.1080/17434440.2022.2038133. Epub 2022 Feb 12. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure
Other Identifiers
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92125179
Identifier Type: -
Identifier Source: org_study_id
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