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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

  Show 27 Study Locations
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