Multiple Cardiac Sensors for the Management of Heart Failure
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.
- Heart Failure, Congestive
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|ICD and CRT-D devices with HeartLogic alerts turned ON||
|ICD and CRT-D devices with HeartLogic alerts turned OFF||
- NCT ID
- Boston Scientific Corporation
Study ContactStephen B Ruble, PhD
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.