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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartLogic ON | Active Comparator | ICD and CRT-D devices with HeartLogic alerts turned ON |
|
| HeartLogic OFF | Placebo Comparator | ICD and CRT-D devices with HeartLogic alerts turned OFF |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartLogic ON | Device | Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Manage-HF Phase I | 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. | Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit |
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Inclusion Criteria:
Subject is age 18 or above, or of legal age to give informed consent
Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
Remotely monitored by LATITUDE 5.0 (or future versions)
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.
Meet at least one of the three following conditions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Hernandez, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Cardiology Associates of Northeast Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35460884 | Derived | 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. | |
| 35129007 |
| Label | URL |
|---|---|
| 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 | View source |
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Manage-HF Phase I began recruitment in August of 2017 and completed recruitment in May of 2019. Last Patient Last visit for Phase I occurred in July of 2020. MANAGE HF Phase I was determined to be sufficient by FDA on January 31, 2023, and phase II was not started.
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| ID | Title | Description |
|---|---|---|
| FG000 | MANAGE-HF Phase I | Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit. Thirty-seven subjects withdrew and 19 subjects died. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2018 |
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| HeartLogic OFF | Device | Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON |
|
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| University of Southern California Hospital | Los Angeles | California | 90033 | United States |
| Cardiovascular Consultants | Oakland | California | 94609 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Parkview Hospital, Inc. | Fort Wayne | Indiana | 46805 | United States |
| Community Health Network | Indianapolis | Indiana | 46250 | United States |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | 71105 | United States |
| Centra Care Heart and Vascular Center | Cold Spring | Minnesota | 56320 | United States |
| United Heart and Vascular | Saint Paul | Minnesota | 55102 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Strong Memorial Hospital of the University of Rochester | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| Lindner Center for Research and Education at Christ Hosp | Cincinnati | Ohio | 45219 | United States |
| Bethesda North Hospital | Cincinnati | Ohio | 45220 | United States |
| PeaceHealth Sacred Heart Medical Center | Springfield | Oregon | 97477 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Stern Cardiovascular | Germantown | Tennessee | 38138 | United States |
| Southeast Texas Clinical Research Center | Beaumont | Texas | 77702 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| L'Hôpital privé du Confluent | Nantes | 44277 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| Universitätsklinikum Würzburg AöR | Würzburg | 97080 | Germany |
| Derived |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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There were 200 subjects enrolled and 191 completed the baseline visit. Demographics, medical history, physical assessment, heart failure assessment, and blood labs were taken at the baseline visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | MANAGE-HF Phase I | Two hundred subjects were enrolled in Phase I of MANAGE-HF. One hundred forty-four subjects were followed until the last patient enrolled completed his or her12-month visit. Thirty-seven subjects withdrew and 19 subjects died. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Heart Failure Hospitalization | Count of Participants | Participants |
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| Ischemic Heart Disease | Count of Participants | Participants |
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| Dilated Cardiomyopathy | Count of Participants | Participants |
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| Idiopathic Cardiomyopathy | Count of Participants | Participants |
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| Valvular disease | Count of Participants | Participants |
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| Valvular surgery | Count of Participants | Participants |
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| Thoracic surgery | Count of Participants | Participants |
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| Previous Myocardial Infarction | Count of Participants | Participants |
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| CABG | Count of Participants | Participants |
| |||||||||||||||||||||||
| QRS duration (ms) | Mean | Standard Deviation | ms |
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| LVEF (%) | Mean | Standard Deviation | % |
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| RVEF (%) | Mean | Standard Deviation | % |
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| Chronic Obstructive Pulmonary Disease | Number | participants |
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| Asthma | Count of Participants | Participants |
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| Pulmonary hypertension | Count of Participants | Participants |
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| Pulmonary diseases other | Count of Participants | Participants |
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| Peripheral Vascular Disease | Count of Participants | Participants |
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| Renal dysfunction | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Manage-HF Phase I | 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. | Manage-HF Phase II was not started, the trial was closed after phase I | Posted | Count of Participants | Participants | Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit |
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Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit
Manage-HF Phase II was not started, the study was closed after Phase I
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MANAGE-HF Phase I | MANAGE-HF Phase I was an open label, non-randomized single arm study | 19 | 200 | 100 | 200 | 104 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulse Generator | Cardiac disorders | Non-systematic Assessment |
| ||
| RA Lead | Cardiac disorders | Non-systematic Assessment |
| ||
| RV Lead | Cardiac disorders | Non-systematic Assessment |
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| Cardiovascular-HF | Cardiac disorders | Non-systematic Assessment |
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| Cardiovascular-Non-HF | Cardiac disorders | Non-systematic Assessment |
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| Non-cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulse Generator | Cardiac disorders | Non-systematic Assessment |
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| RA Lead | Cardiac disorders | Non-systematic Assessment |
| ||
| RV Lead | Cardiac disorders | Non-systematic Assessment |
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| Cardiovascular-HF | Cardiac disorders | Non-systematic Assessment |
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| Cardiovascular-Non-HF | Cardiac disorders | Non-systematic Assessment |
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| Non-cardiovascular | Cardiac disorders | Non-systematic Assessment |
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Patients that were included in Phase I of MANAGE-HF were required to meet inclusion and exclusion criteria. This included evidence of worsened heart failure prior to enrollment, patients with severe kidney impairment or short life expectancy were excluded. Thus, the results are limited to the population that was studied. Furthermore, the small sample size and lack of a control group severely limits the interpretation of the results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joe Hobbs, Clinical Trial Manager | Boston Scientific | 612-206-4703 | JOE.HOBBS@BSCI.COM |
| Nov 6, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Germany |
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