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Trial record 41 of 886 for:    Recruiting, Not yet recruiting, Available Studies | Congestive heart failure

Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF)

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ClinicalTrials.gov Identifier: NCT03237858
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: HeartLogic ON Device: HeartLogic OFF Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multiple Cardiac Sensors for the Management of Heart Failure
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: HeartLogic ON
ICD and CRT-D devices with HeartLogic alerts turned ON
Device: HeartLogic ON
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF

Placebo Comparator: HeartLogic OFF
ICD and CRT-D devices with HeartLogic alerts turned OFF
Device: HeartLogic OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: Expected to take 4 years from first patient enrollment ]
    Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic alerts versus those not managed with alerts. An endpoint event for each subject will be determined by the first occurrence of a heart failure hospitalization or death. A total of 864 endpoint events are needed to detect a difference between the two groups (alpha=0.05; power=90%; hazard ratio of 0.8).

  2. Heart failure hospitalization [ Time Frame: Expected to take 4 years from first patient enrollment ]
    Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic alerts versus those not managed with alerts. An endpoint event for each subject will be determined by the first occurrence of a heart failure hospitalization or death. A total of 864 endpoint events are needed to detect a difference between the two groups (alpha=0.05; power=90%; hazard ratio of 0.8).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237858


Contacts
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Contact: Stephen B Ruble, PhD 651-582-4397 stephen.ruble@bsci.com
Contact: Kate Frost, PhD kate.frost@bsci.com

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Locations
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United States, Alabama
Heart Center Research, LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Jessica Marsh    256-519-8290    jmarsh@theheartcenter.md   
Principal Investigator: Jay Dinerman, MD         
United States, Arkansas
Cardiology Associates of Northeast Arkansas Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Kayla Rubino    870-935-6729    krubino@stbheart.com   
Principal Investigator: Devi Nair, MD         
United States, California
University of Southern California Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Ramos    323-442-7983    melissa.ramos@med.usc.edu   
Principal Investigator: Rahul Doshi, MD         
Cardiovascular Consultants Recruiting
Oakland, California, United States, 94609
Contact: Manginder Sohal    925-274-2078    msohal@stanfordhealthcare.org   
Principal Investigator: Steven Kang, MD         
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Donna Small    858-244-6889    dsmall@sdcardiac.com   
Principal Investigator: Peter Hoagland, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Carol Maguire    415-768-5148    cmaguire@medicine.ucsf.edu   
Principal Investigator: Byron Lee, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kaitlin Ketchum    303-724-6473    kaitlin.ketchum@ucdenver.edu   
Principal Investigator: Larry Allen, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stacy Williams    404-712-0502    stacy.williams@emory.edu   
Principal Investigator: Andrew Smith, MD         
United States, Indiana
Parkview Hospital, Inc. Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Jessica Heffernan    260-266-5614    jessica.heffernan@parkview.com   
Principal Investigator: Mark O/Shaughn, MD         
Community Health Network Recruiting
Indianapolis, Indiana, United States, 46250
Contact: J Kogline    317-621-8621    jkogline@community.com   
Principal Investigator: Chad Bonhomme, MD         
United States, Louisiana
Advanced Cardiovascular Specialists Recruiting
Shreveport, Louisiana, United States, 71105
Contact: Katherine Chalamidas    318-795-4638      
Contact: kchalamidas@acsdoctors.com         
Principal Investigator: Sherman Wiggins, MD         
United States, Minnesota
Centra Care Heart and Vascular Center Recruiting
Cold Spring, Minnesota, United States, 56320
Contact: Jennifer Humbert    320-656-7020    humberj@centracare.com   
Principal Investigator: Moustapha Atoui, MD         
United Heart and Vascular Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Lisa Boben    651-241-2913    lisa.boben@allina.com   
Principal Investigator: Alan Bank, MD         
United States, New Hampshire
Catholic Medical Center Recruiting
Manchester, New Hampshire, United States, 03102
Contact: Elizabeth Cornelius, RN    603-669-0413    elizabeth.cornelius@cmc-nh.org   
Principal Investigator: Robert Capodilupo, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Johanna Oviedo    718-920-8780    joviedo@montefiore.org   
Principal Investigator: Jooyoung Shin, MD         
Strong Memorial Hospital of the University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Laura Wing    585-273-4128    laura_wing@urmc.rochester.edu   
Principal Investigator: Atkas Mehmet, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Susan Gerstl    919-681-8983    susan.gerstl@dm.duke.edu   
Principal Investigator: Jonathan Piccini, MD         
Rex Hospital Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Tiffany Johnson    919-784-4031    tiffany.johnson@unchealth.unc.edu   
Principal Investigator: Sidharth Shah, MD         
United States, Ohio
Lindner Center for Research and Education at Christ Hosp Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jessica Marsh    256-519-8276    jmarsh@theheartcenter.md   
Principal Investigator: Jay Dinnerman, MD         
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Sue Dorroh    513-865-1148    sue_dorroh@trihealth.com   
Principal Investigator: Hemal Shah, MD         
United States, Oregon
PeaceHealth Sacred Heart Medical Center Recruiting
Springfield, Oregon, United States, 97477
Contact: Penny O'Leary    541-222-1927    poleary@peacehealth.org   
Principal Investigator: Matt Trojan, MD         
United States, Pennsylvania
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Dena Jefferson    717-531-5967    djefferson1@hmc.psu.edu   
Principal Investigator: John Boehmer, MD         
Cardiology Consultants of Philadelphia Recruiting
Yardley, Pennsylvania, United States, 19067
Contact: Sharon Budzinski       SharonB@ccpdocs.com   
Principal Investigator: Christopher Schulze, DO         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Deborah Everidge    843-792-2944    adamsde@musc.edu   
Principal Investigator: Michael Gold, MD         
United States, Tennessee
Stern Cardiovascular Recruiting
Germantown, Tennessee, United States, 38138
Contact: Jill Guy    901-271-1000    jill.guy@sterncardio.com   
Principal Investigator: David Lan, MD         
United States, Texas
Southeast Texas Clinical Research Center Recruiting
Beaumont, Texas, United States, 77702
Contact: Mary Ellis    409-839-4003    mellis@setxcardiology.com   
Principal Investigator: Paris Bransford, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Kimberley Judson    757-388-2812    kajudso2@sentara.com   
Principal Investigator: John Herre, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Adrian Hernandez, MD Duke University

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03237858     History of Changes
Other Study ID Numbers: 92125179
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston Scientific Corporation:
heart failure
diagnostics
heart sounds
CRT-D
ICD
remote monitoring
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases