Multiple Cardiac Sensors for the Management of Heart Failure
MANAGE-HF
1 other identifier
interventional
200
3 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedStudy Start
First participant enrolled
August 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2020
CompletedResults Posted
Study results publicly available
March 27, 2024
CompletedMarch 27, 2024
November 1, 2023
2.9 years
July 20, 2017
November 21, 2023
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
HeartLogic ON
ACTIVE COMPARATORICD and CRT-D devices with HeartLogic alerts turned ON
HeartLogic OFF
PLACEBO COMPARATORICD and CRT-D devices with HeartLogic alerts turned OFF
Interventions
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Eligibility Criteria
You may qualify if:
- 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:
- 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
You may not qualify if:
- The subject is unable to sign or refuses to sign the patient informed consent
- Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
- The subject is implanted with unipolar right atrial or right ventricular leads
- Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
- Subject is pregnant or planning to become pregnant during the study
- Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)
- Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
- Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
- A life expectancy of less than 12 months per clinician discretion
- APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
- APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Cardiology Associates of Northeast Arkansas
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
Related Publications (2)
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.
PMID: 35460884DERIVEDHeggermont 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.
PMID: 35129007DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Joe Hobbs, Clinical Trial Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Hernandez, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2017
First Posted
August 3, 2017
Study Start
August 30, 2017
Primary Completion
July 21, 2020
Study Completion
July 21, 2020
Last Updated
March 27, 2024
Results First Posted
March 27, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share