Multiple Cardiac Sensors for the Management of Heart Failure

Purpose

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

  • Heart Failure, Congestive

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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:
  7. At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
  8. Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
  9. 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Johanna Oviedo
718-920-8780
joviedo@montefiore.org

More Details

NCT ID
NCT03237858
Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Stephen B Ruble, PhD
651-582-4397
stephen.ruble@bsci.com

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.