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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

Tracking Information
First Submitted Date  ICMJE July 20, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03237858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Cardiac Sensors for the Management of Heart Failure
Official Title  ICMJE Multiple Cardiac Sensors for the Management of Heart Failure
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure, Congestive
Intervention  ICMJE
  • Device: HeartLogic ON
    Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
  • Device: HeartLogic OFF
    Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Study Arms  ICMJE
  • Active Comparator: HeartLogic ON
    ICD and CRT-D devices with HeartLogic alerts turned ON
    Intervention: Device: HeartLogic ON
  • Placebo Comparator: HeartLogic OFF
    ICD and CRT-D devices with HeartLogic alerts turned OFF
    Intervention: Device: HeartLogic OFF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
2700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephen B Ruble, PhD 651-582-4397 stephen.ruble@bsci.com
Contact: Kate Frost, PhD kate.frost@bsci.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237858
Other Study ID Numbers  ICMJE 92125179
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Hernandez, MD Duke University
PRS Account Boston Scientific Corporation
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP