Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF)

Boston Scientific

Status: Completed

Conditions: Heart Failure, Congestive

Treatments: Device: HeartLogic OFF; Device: HeartLogic ON

Study type: Interventional

Funder types: Industry

Identifiers

NCT03237858

92125179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

HeartLogic ON

Active Comparator group

Description:

ICD and CRT-D devices with HeartLogic alerts turned ON

Treatment:

Device: HeartLogic ON

HeartLogic OFF

Placebo Comparator group

Description:

ICD and CRT-D devices with HeartLogic alerts turned OFF

Treatment:

Device: HeartLogic OFF