Multiple Cardiac Sensors for the Management of Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multiple Cardiac Sensors for the Management of Heart Failure

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: HeartLogic ON
* Device: HeartLogic OFF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HeartLogic ON<br>ICD and CRT-D devices with HeartLogic alerts turned ON | Device: HeartLogic ON<br>* Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF<br>|
| Placebo Comparator: HeartLogic OFF<br>ICD and CRT-D devices with HeartLogic alerts turned OFF | Device: HeartLogic OFF<br>* Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality and heart failure hospitalization | Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic versus those not managed with HeartLogic. | From each patients randomization through final endpoint accrual | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality | This endpoint will compare the Kaplan-Meier curves of all-cause survival between the HeartLogic and control groups. | Subjects that have survived the entire follow-up will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first. | 
| Freedom from heart failure hospitalizations (time-to-first event) | This endpoint will compare the Kaplan-Meier curves of freedom from heart failure hospitalizations between the HeartLogic and control groups | Subjects that have survived without experiencing a heart failure hospitalization at the time of analysis will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first | 
| Risk of multiple heart failure hospitalizations | This endpoint will compare the cause-specific hazard of heart failure hospitalizations between the HeartLogic and control groups. | All heart failure hospitalizations following randomization for each subject in Phase II will contribute to the analysis | 
| Change in NYHA classification | Change in NYHA from baseline through 12 months will be evaluated and compared between the randomized groups. | Baseline and 12 months. | 
| Change in Quality of Life | Change in Quality of Life from baseline through 12 months will be evaluated and compared between the randomized groups . | Baseline and 12 months. | 
| Change in NT-proBNP | Change in NT-proBNP from baseline through 12 months will be evaluated and compared between the randomized groups. | Baseline and 12 months. | 
| Change in Medication Status | Change in medication status throughout the study will be evaluated and compared between the randomized groups. | From each patients randomization through final endpoint accrual. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, diagnostics, heart sounds, CRT-D, ICD, remote monitoring